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Troponin I Rapid Test Cassette (Whole Blood +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref GDTRO-402b
Identity
- Trade Name
- Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Device Name
- Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Model / Reference
- GDTRO-402b EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GDTRO-402bDP EUDAMED
- Basic UDI-DI
- B-GDTRO-402bDP EUDAMED
- EMDN Code
- W0102160703 TROPONIN I/T - RT & POC 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
No
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
Yes
EUDAMED
Troponin I Rapid Test Cassette (Whole Blood +2 more) 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-GDTRO-402bDP | 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 688eb848-7d43-48ad-a4bf-8ea4d7d0b51a 61 fields · synced Jun 19, 2026