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Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry)
EUDAMEDClass C (EU MDR)
Ref 32080147
Identity
- Trade Name
- Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry) EUDAMED
- Device Name
- Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 32080147 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334821540 EUDAMED
- Basic UDI-DI
- 69503348PA041HX EUDAMED
- EMDN Code
- W0102060109 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Bulgaria 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 — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED f75af830-28dd-4575-ad20-f6390f2362fe 61 fields · synced Jun 18, 2026