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sTfR (II) Calibrators
EUDAMEDClass IVD General (EU MDR)
Ref 3000-2338
by Biokit S.A.
Identity
- Trade Name
- sTfR (II) Calibrators EUDAMED
- Device Name
- sTfR (II) Calibrators EUDAMED
- Model / Reference
- 3000-2338 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-3000-2338DK EUDAMED
- Basic UDI-DI
- B-3000-2338DK EUDAMED
- EMDN Code
- W0102152206 ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS 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) Calibrators 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-3000-2338DK | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (1)
- EUDAMED 45d29c8b-87bf-4c7a-aef5-35027328c886 61 fields · synced Aug 3, 2026