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sTfR (II) Controls
EUDAMEDClass IVD General (EU MDR)
Ref 3000-2339
by Biokit S.A.
Identity
- Trade Name
- sTfR (II) Controls EUDAMED
- Device Name
- sTfR (II) Controls EUDAMED
- Model / Reference
- 3000-2339 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-3000-2339DM EUDAMED
- Basic UDI-DI
- B-3000-2339DM EUDAMED
- EMDN Code
- W0102152006 ANAEMIA RELATED/VITAMIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
sTfR (II) Controls by Biokit, S.a. — 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-3000-2339DM | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (1)
- EUDAMED 03007257-e9df-4ae6-92fd-f37370d505c8 61 fields · synced Jul 11, 2026