- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414598390
- Basic UDI-DI
- 0405686901677WB
- Reference
- 10995512
- EMDN
- W0102152299
- EMDN description
- STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
- First on market country
- -
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 20.07.2026 22:45
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
01.08.2026 18:27
Sync status
Successful
Device
2989865
Actor
47523
Certificate
3174
IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768034169
- Basic UDI-DI
- 0405686901053UX
- Reference
- 10470444
- EMDN
- W0102152209
- EMDN description
- DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
- First on market country
- -
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 20.07.2026 22:45
IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414598406
- Basic UDI-DI
- 0405686901677WB
- Reference
- 10995513
- EMDN
- W0102152299
- EMDN description
- STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
- First on market country
- -
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 20.07.2026 22:45
IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768034152
- Basic UDI-DI
- 0405686901053UX
- Reference
- 10470443
- EMDN
- W0102152209
- EMDN description
- DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
- First on market country
- -
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 20.07.2026 22:45
IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768001789
- Basic UDI-DI
- 0405686901074V7
- Reference
- 10445411
- EMDN
- W0102152209
- EMDN description
- DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
- First on market country
- -
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 20.07.2026 22:45
IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768001772
- Basic UDI-DI
- 0405686901074V7
- Reference
- 10445410
- EMDN
- W0102152209
- EMDN description
- DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
- First on market country
- -
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 20.07.2026 22:45
IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768001765
- Basic UDI-DI
- 0405686901074V7
- Reference
- 10445409
- EMDN
- W0102152209
- EMDN description
- DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
- First on market country
- -
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 20.07.2026 22:45
IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768001741
- Basic UDI-DI
- 0405686901074V7
- Reference
- 10445407
- EMDN
- W0102152209
- EMDN description
- DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
- First on market country
- -
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 20.07.2026 22:45
Emit II Plus 6-AM/Ecstasy Calibrator/Control Level 1
IVDR_67_GLA_DUB-C_B_REAG_6-AM/Ecstasy Cals/Ctls Levels 1-4
IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768034138
- Basic UDI-DI
- 0405686901053UX
- Reference
- 10470441
- 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
- 17.07.2026 22:42
Dimension CardioPhase high sensitivity C-reactive protein Calibrator
IVDR_67_GLA_DUB-C_C_REAG_CCRP CAL
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768016011
- Basic UDI-DI
- 0405686901078VF
- Reference
- 10445003
- EMDN
- W0102152204
- EMDN description
- CARDIAC MARKER STANDARDS AND CALIBRATORS
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 17.07.2026 22:42
Emit 2000 Cyclosporine Specific Calibrators
IVDR_67_GLA_DUB-C_C_REAG_Cyclosporine Specific Calibrators
IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768001468
- Basic UDI-DI
- 0405686901250V3
- Reference
- 10445376
- EMDN
- W0102152201
- EMDN description
- TDM/DRUG STANDARDS AND CALIBRATORS
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 17.07.2026 22:42
Emit Antiepileptic Drug Calibrators
IVDR_67_GLA_DUB-C_C_REAG_Antiepileptic Drug Calibrators
IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768001253
- Basic UDI-DI
- 0405686901061UW
- Reference
- 10445353
- EMDN
- W0102152201
- EMDN description
- TDM/DRUG STANDARDS AND CALIBRATORS
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 17.07.2026 22:41
Emit 2000 Gentamicin Plus Calibrators
IVDR_67_GLA_DUB-C_B_REAG_Gentamicin Plus Calibrators
IVD Class CIVDR 2017/746On the marketProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768001093
- Basic UDI-DI
- 0405686901119V4
- Reference
- 10445334
- EMDN
- W0102152201
- EMDN description
- TDM/DRUG STANDARDS AND CALIBRATORS
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 17.07.2026 22:41
Emit 2000 Digoxin Calibrators
IVDR_67_GLA_DUB-C_C_REAG_Digoxin Calibrators
IVD Class CIVDR 2017/746On the marketProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768000973
- Basic UDI-DI
- 0405686901255VD
- Reference
- 10445316
- EMDN
- W0102152201
- EMDN description
- TDM/DRUG STANDARDS AND CALIBRATORS
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 17.07.2026 22:41
Emit 2000 Carbamazepine Calibrators
IVDR_67_GLA_DUB-C_B_REAG_Carbamazepine Calibrators
IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768000935
- Basic UDI-DI
- 0405686901076VB
- Reference
- 10445310
- EMDN
- W0102152201
- EMDN description
- TDM/DRUG STANDARDS AND CALIBRATORS
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 17.07.2026 22:41
Atellica IM Her-2/neu Quality Control (H2n QC)
IVDR_67_TTN_DUB-C_C_REAG_H2n QC
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414599182
- Basic UDI-DI
- 0405686901854W9
- Reference
- 10995594
- EMDN
- W0102152205
- EMDN description
- TUMOUR MARKER STANDARDS AND CALIBRATORS
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 17.07.2026 22:40
Atellica IM HER-2/neu Calibrator (H2n CAL)
IVDR_67_TTN_DUB-C_C_REAG_H2n Cal
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414599168
- Basic UDI-DI
- 0405686901853W7
- Reference
- 10995592
- EMDN
- W0102152205
- EMDN description
- TUMOUR MARKER STANDARDS AND CALIBRATORS
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 17.07.2026 22:40
Atellica IM BR 27.29 Calibrator (BR CAL)
IVDR_67_TTN_DUB-C_C_REAG_BR CAL
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414598420
- Basic UDI-DI
- 0405686901826W4
- Reference
- 10995515
- EMDN
- W0102152205
- EMDN description
- TUMOUR MARKER STANDARDS AND CALIBRATORS
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 17.07.2026 22:40
ADVIA Centaur Calibrator Y (CAL Y)
IVDR_67_TTN_DUB-C_C_REAG_CAL Y
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414451114
- Basic UDI-DI
- 0405686901833VZ
- Reference
- 10310383
- EMDN
- W0102152299
- EMDN description
- STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 17.07.2026 22:39
ADVIA Centaur Calibrator G (CAL G)
IVDR_67_TTN_DUB-C_C_REAG_Calibrator G
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414182254
- Basic UDI-DI
- 0405686901836W7
- Reference
- 10337270
- EMDN
- W0102152299
- EMDN description
- STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 17.07.2026 22:39