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Alinity c Myoglobin Reagent Kit
EUDAMEDClass C (EU MDR)
Ref 01R1523Ref 01R1522
by Biokit S.A.
Identity
- Trade Name
- Alinity c Myoglobin Reagent Kit EUDAMED
- Device Name
- Alinity c Myoglobin Reagent Kit EUDAMED
- Model / Reference
- 01R1523 EUDAMED01R1522 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436003070962 EUDAMEDD-01R15226R EUDAMED
- Basic UDI-DI
- 8436003070498Y7 EUDAMEDB-01R15226R EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General 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
Alinity c Myoglobin Reagent Kit by Biokit, S.a. — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 8436003070498Y7 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 8436003070498Y7 | Class C | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (2)
- EUDAMED 55fcb763-269a-445c-b3f8-d3cb9af58e2b 61 fields · synced Jul 16, 2026
- EUDAMED d6675fbe-d43f-4877-ab83-d893a5a67200 61 fields · synced May 18, 2026