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EUDAMED Device Search

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

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20.09.2026 19:38

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114 device results listed.

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IDS ANA Control Set

IDS ANA Control Set

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693883
Basic UDI-DI: B-05060169693883
Reference: IS-AI1130
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 05.08.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

IDS t-TG IgG Control Set

IDS t-TG IgG Control Set

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169694217
Basic UDI-DI: B-05060169694217
Reference: IS-AI1430
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details

IDS CELIAC Control Set

IDS CELIAC Control Set

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169694200
Basic UDI-DI: B-05060169694200
Reference: IS-AI1330
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details

IDS APS IgM Control Set

IDS APS IgM Control Set

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169694194
Basic UDI-DI: B-05060169694194
Reference: IS-AI1630
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details

IDS CCP Control Set

IDS CCP Control Set

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169694071
Basic UDI-DI: B-05060169694071
Reference: IS-AI1230
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details

IDS ANA Screen Control Set

IDS ANA Screen Control Set

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693890
Basic UDI-DI: B-05060169693890
Reference: IS-AI1030
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

CUSTOM LIQUID THERAPEUTIC DRUG CONTROL - LEVEL 1

CUSTOM LIQUID THERAPEUTIC DRUG CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217315
Basic UDI-DI: 50552732BLTDCON177KM
Reference: HD3145
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

LITHIUM CONTROL

LITHIUM CONTROL

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700824725
Basic UDI-DI: 37017008LITH05BZ
Reference: LITH-0048
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:51

Manufacturer products View details

Serum Drug Control Module

IVDR_67_LLB_DUB-C_C_REAG_Serum Drug Control Module

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953410
Basic UDI-DI: 0405686901488W6
Reference: 10385397
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

LITHIUM CONTROL

-

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700824732
Basic UDI-DI: 37017008LITH05BZ
Reference: LITH-4080
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 02:21

Manufacturer products View details

Mycophenolic Acid Control

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: More Diagnostics Inc
Manufacturer SRN: US-MF-000019469
UDI-DI: 00856743007062
Basic UDI-DI: 0856743007MDI02406D
Reference: 240
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

Cyclosporine C2 Control

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: More Diagnostics Inc
Manufacturer SRN: US-MF-000019469
UDI-DI: 00856743007055
Basic UDI-DI: 0856743007MDI020265
Reference: 202
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

N aTNFa Controls ADA

IVDR_27_MAR EB_B_N_aTNFa_Con_ADA_ETA_INF

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414615400
Basic UDI-DI: 0405686902180VE
Reference: 10873740
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:36

Manufacturer products View details

Emit II Plus Specialty Multi Drug Calibrator/Control Level 4

IVDR_67_GLA_DUB-C_B_REAG_Spl Multi Drug 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: 00630414027944
Basic UDI-DI: 0405686901901VR
Reference: 10720815
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Oxycodone Positive Control 300

IVDR_67_GLA_DUB-C_B_REAG_Oxycodone Pos and Neg Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027975
Basic UDI-DI: 0405686901154V6
Reference: 10720812
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Mycophenolic Acid Controls

IVDR_67_LLB_DUB-C_C_REAG_Mycophenolic Acid_Cnt

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414168289
Basic UDI-DI: 0405686900733VM
Reference: 10730960
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Ketamine Control Solution (FIA)

VIC39

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC3935
Basic UDI-DI: B-VIC3935
Reference: VIC39-09-011
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:18

Manufacturer products Authorised representative products Authorised representative actors View details

Drug of Abuse Control Solution (FIA)

VIC153

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC153ET
Basic UDI-DI: B-VIC153ET
Reference: VIC153-09-011
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:18

Manufacturer products Authorised representative products Authorised representative actors View details

Digoxin Control Solution (FIA)

VIC147

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC147EY
Basic UDI-DI: B-VIC147EY
Reference: VIC147-13-011
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:18

Manufacturer products Authorised representative products Authorised representative actors View details

Cystatin C Control Solution (FIA)

VIC03

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC032G
Basic UDI-DI: B-VIC032G
Reference: VIC03-02-011
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:17

Manufacturer products Authorised representative products Authorised representative actors View details