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cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)
EUDAMEDClass IVD General (EU MDR)
Ref FDCAR-T402a
Identity
- Trade Name
- cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA) EUDAMED
- Device Name
- cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA) EUDAMED
- Model / Reference
- FDCAR-T402a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FDCAR-T402aXH EUDAMED
- Basic UDI-DI
- B-FDCAR-T402aXH EUDAMED
- EMDN Code
- W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER 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
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA) 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-FDCAR-T402aXH | 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 1ceb1e56-da7a-4f17-ad85-3c7ceaa68f75 61 fields · synced Jun 19, 2026