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Myoglobin STAT (EECL)
EUDAMEDClass IVD General (EU MDR)
Ref 1040502000Model 50 tests/kitRef 1040501000Model 25 tests/kitRef 1040512000Model 100 tests/kit
Identity
- Device Name
- Myoglobin STAT (EECL) EUDAMED
- Model / Reference
- 50 tests/kit EUDAMED1040502000 EUDAMED25 tests/kit EUDAMED1040501000 EUDAMED100 tests/kit EUDAMED1040512000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975090501444 EUDAMED06975090500447 EUDAMED06975090503448 EUDAMED
- Basic UDI-DI
- B-06975090501444 EUDAMEDB-06975090500447 EUDAMEDB-06975090503448 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
Classification
- Device Class
- Class 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
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Myoglobin STAT (EECL) by Accucise Diagnostics Inc. — 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-06975090501444 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Accucise Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000045017
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED 4dc22294-5776-4bd2-ac04-ce1328c69e9f 61 fields · synced Jul 13, 2026
- EUDAMED 7eeaf447-e877-4790-b0d0-a4fd7072b416 61 fields · synced May 18, 2026
- EUDAMED 35960b5f-b435-47fe-9b36-1be771ef52d2 61 fields · synced May 18, 2026