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Myoglobin Rapid Test Cassette - Plasma
EUDAMEDClass IVD General (EU MDR)
Ref GDMYO-402a
Identity
- Trade Name
- Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Device Name
- Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Model / Reference
- GDMYO-402a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GDMYO-402aD7 EUDAMED
- Basic UDI-DI
- B-GDMYO-402aD7 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
- Models / Variants
- Whole Blood EUDAMEDSerum EUDAMEDPlasma EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Myoglobin Rapid Test Cassette - Plasma by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — 3 models
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-GDMYO-402aD7 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED de5525e9-7976-468f-b0ea-844422aafa13 61 fields · synced Jun 18, 2026