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Quantia Myoglobin
EUDAMEDClass IVD General (EU MDR)
Ref 6L32-43Ref 6L32-44
by Biokit S.A.
Identity
- Trade Name
- Quantia Myoglobin EUDAMED
- Device Name
- Quantia Myoglobin EUDAMED
- Model / Reference
- 6L32-43 EUDAMED6L32-44 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6L32-439E EUDAMED08436003070955 EUDAMED
- Basic UDI-DI
- B-6L32-439E EUDAMED8436003070511X6 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
Quantia Myoglobin by Biokit, S.a. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-6L32-439E | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-6L32-439E | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (2)
- EUDAMED 2d0fca06-d16a-4e62-9c1d-8506c3c24e75 61 fields · synced Jul 13, 2026
- EUDAMED 9df8286f-1237-4f30-8203-10cfbc408b4c 61 fields · synced May 18, 2026