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Homocysteine Kit (Dry Chemistry Method)
EUDAMEDClass IVD General (EU MDR)
Ref DC2202AModel 20T
Identity
- Trade Name
- Homocysteine Kit (Dry Chemistry Method) EUDAMED
- Device Name
- Homocysteine Kit (Dry Chemistry Method) EUDAMED
- Model / Reference
- 20T EUDAMEDDC2202A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978945081023 EUDAMED
- Basic UDI-DI
- B-06978945081023 EUDAMED
- EMDN Code
- W01021307 HOMOCYSTEINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Homocysteine Kit (Dry Chemistry Method) by Jiangxi Medicalsystem Biological Technology 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-06978945081023 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000050651
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 566ad784-8b70-4f0e-ad8d-b12fb188c337 61 fields · synced Jul 15, 2026