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In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 1MYOB12
Identity
- Trade Name
- In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay) EUDAMED
- Device Name
- In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay) EUDAMED
- Model / Reference
- 1MYOB12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950996004404 EUDAMED
- Basic UDI-DI
- B-06950996004404 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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
In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06950996004404 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 537eee77-c0e4-45ab-8804-2475da7bbfa8 61 fields · synced Jul 22, 2026