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Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 50 Tests/KitRef 100 Tests/KitRef 25 Tests/Kit
Identity
- Trade Name
- Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 50 Tests/Kit EUDAMED100 Tests/Kit EUDAMED25 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986814903 EUDAMED06974986814910 EUDAMED06974986814897 EUDAMED
- Basic UDI-DI
- B-06974986814903 EUDAMEDB-06974986814910 EUDAMEDB-06974986814897 EUDAMED
- EMDN Code
- W0102120199 LIVER FUNCTION - OTHER 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock 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-06974986814903 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED a3f09535-dc1f-45d3-9395-a9445c25fff4 61 fields · synced Oct 6, 2026
- EUDAMED 570f39b5-38d6-465c-a2d5-7dddd37a71a5 61 fields · synced May 17, 2026
- EUDAMED 967eb043-d596-4ac8-9d1f-bf829ec4a581 61 fields · synced May 17, 2026