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Myoglobin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2041E-25Ref S2041E-50Ref S2041E-200
Identity
- Device Name
- Myoglobin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2041E-25 EUDAMEDS2041E-50 EUDAMEDS2041E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792739284 EUDAMED06955792739291 EUDAMED06955792739338 EUDAMED
- Basic UDI-DI
- B-06955792739284 EUDAMEDB-06955792739291 EUDAMEDB-06955792739338 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Myoglobin Chemiluminescence Immunoassay Kit by Sansure Biotech 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-06955792739284 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED a7dff10f-efa9-471f-97bd-33032e23d7d6 61 fields · synced Jul 12, 2026
- EUDAMED 147c8abc-1f67-4248-a9fd-0dac0540cd19 61 fields · synced May 18, 2026
- EUDAMED ba4af20c-8ba5-47b8-bb28-02d3fa29c039 61 fields · synced May 18, 2026