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Glycated Hemoglobin (HbA1c) Detection Kit (Nephelometry)
EUDAMEDClass IVD General (EU MDR)
Ref 32026008Model 25 tests
Identity
- Trade Name
- Glycated Hemoglobin (HbA1c) Detection Kit (Nephelometry) EUDAMED
- Device Name
- Glycated Hemoglobin (HbA1c) Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 25 tests EUDAMED32026008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-PA00024Z EUDAMED
- Basic UDI-DI
- B-PA00024Z EUDAMED
- EMDN Code
- W0102060109 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
Glycated Hemoglobin (HbA1c) Detection Kit (Nephelometry) by Genrui Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-PA00024Z | Class IVD General | 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 b643a0e1-98c4-4bfb-a202-e5c1dca94814 61 fields · synced Jun 18, 2026