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BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT2501-HBA1CModel BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)
Identity
- Trade Name
- BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay) EUDAMED
- Device Name
- HbA1c Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay) EUDAMEDBT2501-HBA1C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260214297 EUDAMED
- Basic UDI-DI
- B-06933260214297 EUDAMED
- EMDN Code
- W0102060109 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay) by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06933260214297 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 7e3d89e5-fcf0-4fcb-947b-865dd5efe909 61 fields · synced Jun 18, 2026