Identity
- Device Name
- FDP Controls EUDAMED
- Model / Reference
- 1ml*10 EUDAMEDHE50124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975838801232 EUDAMED
- Basic UDI-DI
- B-06975838801232 EUDAMED
- EMDN Code
- W010302080501 HEMOSTASIS CONTROLS RT & POC 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
FDP Controls by Zhejiang Pushkang 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-06975838801232 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Pushkang Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000042656
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 08219b62-5441-4951-9b4b-9994e80e53e6 61 fields · synced Jul 22, 2026