Identity
- Trade Name
- HCY Rapid Quantitative Test EUDAMED
- Device Name
- HCY Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- BT2221 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260208715 EUDAMED
- Basic UDI-DI
- B-06933260208715 EUDAMED
- EMDN Code
- W01021307 HOMOCYSTEINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HCY Rapid Quantitative Test by Xiamen Biotime Biotechnology Co., Ltd. — 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-06933260208715 | 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 188b040c-4fbe-4c39-a7a5-717091f34950 61 fields · synced Jul 14, 2026