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Quantia Ferritin/ Myoglobin/IgE Control
EUDAMEDClass C (EU MDR)
Ref 6K56-02
by Biokit S.A.
Identity
- Trade Name
- Quantia Ferritin/ Myoglobin/IgE Control EUDAMED
- Device Name
- Quantia Ferritin/ Myoglobin/IgE Control EUDAMED
- Model / Reference
- 6K56-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00380740157487 EUDAMED
- Basic UDI-DI
- 8436003070535XL EUDAMED
- EMDN Code
- W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
Classification
- Device Class
- Class C 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
New Device
No
EUDAMED
Quantia Ferritin/ Myoglobin/IgE Control by Biokit, S.a. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8436003070535XL | Class C | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (1)
- EUDAMED 6da966ab-7710-4962-b770-7b1c013ab4c4 61 fields · synced Jul 11, 2026