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CrinoCheck E2 Quantitativer Schnelltest (Fluoreszenz Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT2212-E2Model BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)
Identity
- Trade Name
- CrinoCheck E2 Quantitativer Schnelltest (Fluoreszenz Immunoassay) EUDAMED
- Device Name
- E2 Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay) EUDAMEDBT2212-E2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260214303 EUDAMED
- Basic UDI-DI
- B-06933260214303 EUDAMED
- EMDN Code
- W0102050103 ESTRADIOL 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
CrinoCheck E2 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-06933260214303 | 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 c60ee033-76ae-4ca6-b7a9-fe79d3894816 61 fields · synced Aug 4, 2026