Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TR EN

Last updated

24.09.2026 03:47

Sync status

Successful

Device

3604676

Actor

47857

Certificate

3404

Filters

Show filters

Active filter:Manufacturer SRN:US-MF-000016336

379 device results listed.

Page 6 / 19

CSV XML

Emit II Plus Specialty Drug Calibrator / Control Level 1

IVDR_67_GLA_DUB-C_B_REAG_Specialty Drug Cals/Ctls Levels 1-4

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601137
Basic UDI-DI: 0405686901190VA
Reference: 10720049
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 06.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Specialty Drug Control Positive

IVDR_67_GLA_DUB-C_B_REAG_Specialty Drug Controls Neg and Pos

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601090
Basic UDI-DI: 0405686901191VC
Reference: 10718701
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 06.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Ecstasy Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768021947
Basic UDI-DI: 0405686901098VM
Reference: 10445478
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Cyclosporine Sample Pretreatment Reagent

IVDR_67_GLA_DUB-C_C_REAG_Cyclosporine Samp Pretreatment Reag

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001482
Basic UDI-DI: 0405686901248VG
Reference: 10445378
EMDN: W0102080602
EMDN description: CYCLOSPORINE SPECIFIC
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:39

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Absorbance Flex reagent cartridge

IVDR_67_GLA_DUB-C_A_REAG_CHK

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768033117
Basic UDI-DI: 0405686901028UY
Reference: 10481508
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:39

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Specialty Drug Calibrator / Control Level 2

IVDR_67_GLA_DUB-C_B_REAG_Specialty Drug Cals/Ctls Levels 1-4

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601144
Basic UDI-DI: 0405686901190VA
Reference: 10720050
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Specialty Drug Calibrator / Control Level 4

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601168
Basic UDI-DI: 0405686901190VA
Reference: 10720052
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Mass Creatine Kinase MB Isoenzyme Calibrator

IVDR_67_GLA_DUB-C_C_REAG_MMB CAL

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013706
Basic UDI-DI: 0405686901281VE
Reference: 10445023
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Thyroid Calibrator

IVDR_67_GLA_DUB-C_B_REAG_THY CAL

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013683
Basic UDI-DI: 0405686901198VS
Reference: 10445018
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Drugs of Abuse Negative Control

IVDR_67_GLA_DUB-C_B_REAG_DOA Negative Control

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005145
Basic UDI-DI: 0405686901095VF
Reference: 10445032
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Drugs of Abuse Positive Control

IVDR_67_GLA_DUB-C_B_REAG_DOA Positive Control

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005138
Basic UDI-DI: 0405686901096VH
Reference: 10445033
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Chemistry II Calibrator

IVDR_67_GLA_DUB-C_B_REAG_Chemistry II Calibrator

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768004995
Basic UDI-DI: 0405686901080V2
Reference: 10444997
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Enzyme Verifier

IVDR_67_GLA_DUB-C_B_REAG_Enzyme Verifier

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768004988
Basic UDI-DI: 0405686901104UP
Reference: 10445016
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Ethyl Alcohol Negative Calibrator

IVDR_67_GLA_DUB-C_B_REAG_Ethyl Alcohol Cals and Controls

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001970
Basic UDI-DI: 0405686901108UX
Reference: 10445445
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Calibrator B Level 1 (cutoff)

IVDR_67_GLA_DUB-C_B_REAG_Cal B Lev 1 (cutoff) Lev 2 (high)

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001796
Basic UDI-DI: 0405686901071UZ
Reference: 10445412
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Emit tox Acetaminophen Assay

IVDR_67_GLA_DUB-C_C_REAG_Acetaminophen Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001550
Basic UDI-DI: 0405686901227V8
Reference: 10445385
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI High Sensitivity Troponin I Calibrator

IVDR_67_GLA_DUB-C_C_REAG_TNIH_Cal

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414180380
Basic UDI-DI: 0405686900217UW
Reference: 10719483
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Ethyl Alcohol Low Control

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001987
Basic UDI-DI: 0405686901108UX
Reference: 10445447
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Ethyl Alcohol High Control

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002007
Basic UDI-DI: 0405686901108UX
Reference: 10445449
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Alkaline Phosphatase Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_ALPI

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768039010
Basic UDI-DI: 0405686900198VK
Reference: 10642445
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:20

Manufacturer products Authorised representative products Authorised representative actors View details