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Glycosylated Hemoglobin test (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref HGCL59Model Please see the IFU
Identity
- Trade Name
- Glycosylated Hemoglobin test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Glycosylated Hemoglobin test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGCL59 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975417760066 EUDAMED
- Basic UDI-DI
- 697029753288M4 EUDAMED
- EMDN Code
- W0103010202 HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Glycosylated Hemoglobin test (Chemiluminescence Immunoassay) by Beijing Hotgen Biotech Co., Ltd. — Class C — IVDR — listed in EUDAMED
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 | 697029753288M4 | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Hotgen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000015566
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED e422e4d4-580d-4eff-8570-ecc6f277b84b 61 fields · synced Jul 11, 2026