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Hemoglobin A1c (HbA1c) Test Kit (Homogeneous Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref HCLIA15105
Identity
- Trade Name
- Hemoglobin A1c (HbA1c) Test Kit (Homogeneous Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Hemoglobin A1c (HbA1c) Test Kit (Homogeneous Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- HCLIA15105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974524061684 EUDAMED
- Basic UDI-DI
- B-06974524061684 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Hemoglobin A1c (HbA1c) Test Kit (Homogeneous Chemiluminescence Immunoassay) by Nanjing Poclight Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974524061684 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Poclight Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000039609
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (1)
- EUDAMED 1d5be5d0-3ed9-4f16-b3e4-798fb8507ac2 61 fields · synced Jul 14, 2026