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Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry)
EUDAMEDClass C (EU MDR)
Ref 32026008Ref 32026147Ref 32080008Ref 32027156Ref 32027008Model 2*25 tests
Identity
- Trade Name
- Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry) EUDAMEDGlycated Hemoglobin (HbA1c) Detection Kit (Nephelometry) EUDAMED
- Device Name
- Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry) EUDAMEDGlycated Hemoglobin (HbA1c) Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 32026008 EUDAMED32026147 EUDAMED32080008 EUDAMED32027156 EUDAMED32027008 EUDAMED2*25 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334804079 EUDAMED06950334821533 EUDAMED06950334802174 EUDAMED06950334821557 EUDAMED06950334800927 EUDAMEDD-PA00014X EUDAMED
- Basic UDI-DI
- 69503348PA041HX EUDAMEDB-PA00014X EUDAMED
- EMDN Code
- W0102060109 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Bulgaria EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry) by Genrui Biotech Inc. — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69503348PA041HX | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 69503348PA041HX | Class C | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED 55f8c72a-662b-4fcb-ad3e-9a4fcdb98add 61 fields · synced Aug 5, 2026
- EUDAMED 20fa770b-de4f-4116-93e6-3a20f9b3a170 61 fields · synced May 17, 2026
- EUDAMED 3e6d7d4d-f5ca-4620-aa28-b786de9fa0fd 61 fields · synced May 17, 2026
- EUDAMED d1b8a1fb-3c10-4493-99f6-1544a02118ce 61 fields · synced May 18, 2026
- EUDAMED c7091e5d-d537-4a70-bb08-9ae33e84a823 61 fields · synced May 18, 2026
- EUDAMED 4133f42c-dd13-4b36-a096-1aebf1eae813 61 fields · synced May 19, 2026