- Manufacturer
- Affimedix, Inc.
- Manufacturer SRN
- US-MF-000053178
- UDI-DI
- 00850082432172
- Basic UDI-DI
- B-00850082432172
- Reference
- 1156-VDC
- EMDN
- W0101050299
- EMDN description
- SPECIFIC CONTROLS (CC) - OTHER
- First on market country
- Belgium
- Authorised representative
- QbD RepS BV
- Last updated
- 06.08.2026 06:57
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
24.09.2026 15:07
Sync status
Successful
Device
3609459
Actor
47878
Certificate
3408
IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
GLUCO TEST Plus Kontrolllösung hoch
Blood Glucose Control Solution
IVD Annex II List BIVDDOn the marketInstrumentNear-patient testingProfessional testingReagentSelf testing
- Manufacturer
- TaiDoc Technology Corporation
- Manufacturer SRN
- TW-MF-000017956
- UDI-DI
- 04251575910478
- Basic UDI-DI
- B-04251575910478
- Reference
- TD-4912
- EMDN
- W0101050205
- EMDN description
- DIABETES CONTROLS
- First on market country
- Germany
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 05.08.2026 10:04
GLUCO TEST DUO Kontrolllösung hoch
Blood Glucose Control Solution
IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing
- Manufacturer
- TaiDoc Technology Corporation
- Manufacturer SRN
- TW-MF-000017956
- UDI-DI
- 04251575910454
- Basic UDI-DI
- B-04251575910454
- Reference
- TD-4908
- EMDN
- W0101050205
- EMDN description
- DIABETES CONTROLS
- First on market country
- Germany
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 05.08.2026 10:04
CK-MB Control
CK-MB Control
IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent
- Manufacturer
- Thermo Fisher Scientific Oy
- Manufacturer SRN
- FI-MF-000001479
- UDI-DI
- 16438153819087
- Basic UDI-DI
- 6438153BU00050BG
- Reference
- 981908
- EMDN
- W0101050201
- EMDN description
- ENZYME CONTROLS
- First on market country
- Finland
- Authorised representative
- -
- Last updated
- 04.08.2026 22:00
Lipotrol
Lipotrol
IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent
- Manufacturer
- Thermo Fisher Scientific Oy
- Manufacturer SRN
- FI-MF-000001479
- UDI-DI
- 16438153816536
- Basic UDI-DI
- 6438153BU00141BL
- Reference
- 981653
- EMDN
- W0101050202
- EMDN description
- LIPID CONTROLS
- First on market country
- Finland
- Authorised representative
- -
- Last updated
- 04.08.2026 22:00
CK-MB Control High
CK-MB Control High
IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent
- Manufacturer
- Thermo Fisher Scientific Oy
- Manufacturer SRN
- FI-MF-000001479
- UDI-DI
- 16438153812552
- Basic UDI-DI
- 6438153BU00051BJ
- Reference
- 981255
- EMDN
- W0101050201
- EMDN description
- ENZYME CONTROLS
- First on market country
- Finland
- Authorised representative
- -
- Last updated
- 04.08.2026 21:59
Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3)
Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3)
IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent
- Manufacturer
- Randox Laboratories Limited
- Manufacturer SRN
- XI-MF-000028410
- UDI-DI
- 05055273217926
- Basic UDI-DI
- 50552732BLBCNL30345F
- Reference
- BR10391
- EMDN
- W0101050203
- EMDN description
- BILIRUBIN CONTROLS
- First on market country
- Northern Ireland
- Authorised representative
- -
- Last updated
- 04.08.2026 21:34
ADA, KIT DE CONTROL
ADENOSINA DESAMINASA CONTROLES
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- QUIMICA CLINICA APLICADA S.A.
- Manufacturer SRN
- ES-MF-000001512
- UDI-DI
- 18430155008863
- Basic UDI-DI
- B-18430155008863
- Reference
- 993240
- EMDN
- W0101050201
- EMDN description
- ENZYME CONTROLS
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 04.08.2026 18:47
FUJI DRI-CHEM ELECTROLYTE CONTROL QE
FUJI DRI-CHEM ELECTROLYTE CONTROL QE
IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use
- Manufacturer
- FUJIFILM Corporation
- Manufacturer SRN
- JP-MF-000010401
- UDI-DI
- 14902520282672
- Basic UDI-DI
- B-14902520282672
- Reference
- 14902520282672
- EMDN
- W0101050204
- EMDN description
- ELECTROLYTE CONTROLS
- First on market country
- Netherlands
- Authorised representative
- FUJIFILM Healthcare Europe GmbH
- Last updated
- 04.08.2026 18:40
Lipid Control Serum
Level2: 3×1mL
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- DIRUI INDUSTRIAL CO., LTD
- Manufacturer SRN
- CN-MF-000001891
- UDI-DI
- 06942202247255
- Basic UDI-DI
- B-06942202247255
- Reference
- 3003171
- EMDN
- W0101050202
- EMDN description
- LIPID CONTROLS
- First on market country
- Austria
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 03.08.2026 17:16
Lipid Control Serum
Level2: 1×1mL
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- DIRUI INDUSTRIAL CO., LTD
- Manufacturer SRN
- CN-MF-000001891
- UDI-DI
- 06942202247248
- Basic UDI-DI
- B-06942202247248
- Reference
- 3003169
- EMDN
- W0101050202
- EMDN description
- LIPID CONTROLS
- First on market country
- Austria
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 03.08.2026 17:16
Lipid Control Serum
Level1: 3×1mL
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- DIRUI INDUSTRIAL CO., LTD
- Manufacturer SRN
- CN-MF-000001891
- UDI-DI
- 06942202247231
- Basic UDI-DI
- B-06942202247231
- Reference
- 3003165
- EMDN
- W0101050202
- EMDN description
- LIPID CONTROLS
- First on market country
- Austria
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 03.08.2026 17:16
Lipid Control Serum
Level1: 1×1mL
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- DIRUI INDUSTRIAL CO., LTD
- Manufacturer SRN
- CN-MF-000001891
- UDI-DI
- 06942202247224
- Basic UDI-DI
- B-06942202247224
- Reference
- 3003163
- EMDN
- W0101050202
- EMDN description
- LIPID CONTROLS
- First on market country
- Austria
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 03.08.2026 17:16
Specific Protein Control Serum
Level2: 1×1mL
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- DIRUI INDUSTRIAL CO., LTD
- Manufacturer SRN
- CN-MF-000001891
- UDI-DI
- 06942202247217
- Basic UDI-DI
- B-06942202247217
- Reference
- 3003157
- EMDN
- W0101050299
- EMDN description
- SPECIFIC CONTROLS (CC) - OTHER
- First on market country
- Austria
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 03.08.2026 17:16
Specific Protein Control Serum
Level1: 1×1mL
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- DIRUI INDUSTRIAL CO., LTD
- Manufacturer SRN
- CN-MF-000001891
- UDI-DI
- 06942202247200
- Basic UDI-DI
- B-06942202247200
- Reference
- 3003151
- EMDN
- W0101050299
- EMDN description
- SPECIFIC CONTROLS (CC) - OTHER
- First on market country
- Austria
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 03.08.2026 17:16
06930317801059
Type C4: R1, R2, R3 and R4 (4 pcs. respectively)
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- Manufacturer SRN
- CN-MF-000001133
- UDI-DI
- 06930317801059
- Basic UDI-DI
- B-06930317801059
- Reference
- DNK-1901-2
- EMDN
- W0101050299
- EMDN description
- SPECIFIC CONTROLS (CC) - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 03.08.2026 12:35
06930317801042
Type C2: R1, R2, R3 and R4 (2 pcs. respectively)
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- Manufacturer SRN
- CN-MF-000001133
- UDI-DI
- 06930317801042
- Basic UDI-DI
- B-06930317801042
- Reference
- DNK-1901-2
- EMDN
- W0101050299
- EMDN description
- SPECIFIC CONTROLS (CC) - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 03.08.2026 12:35
06930317801035
Type C1: R1, R2, R3 and R4 (1 pc. respectively)
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- Manufacturer SRN
- CN-MF-000001133
- UDI-DI
- 06930317801035
- Basic UDI-DI
- B-06930317801035
- Reference
- DNK-1901-2
- EMDN
- W0101050299
- EMDN description
- SPECIFIC CONTROLS (CC) - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 03.08.2026 12:34
06930317801028
Type B4: R1, R2 and R4 (4 pcs. respectively)
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- Manufacturer SRN
- CN-MF-000001133
- UDI-DI
- 06930317801028
- Basic UDI-DI
- B-06930317801028
- Reference
- DNK-1901-2
- EMDN
- W0101050299
- EMDN description
- SPECIFIC CONTROLS (CC) - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 03.08.2026 12:34
06930317800809
Type A1: R2 and R4 (1 pc. respectively)
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- Manufacturer SRN
- CN-MF-000001133
- UDI-DI
- 06930317800809
- Basic UDI-DI
- B-06930317800809
- Reference
- DNK-1901-2
- EMDN
- W0101050299
- EMDN description
- SPECIFIC CONTROLS (CC) - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 03.08.2026 12:34