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Collagen Type IV (CIV) eCLIA
EUDAMEDClass IVD General (EU MDR)
Ref 692021Model 50T,Ref 692013Model 100TRef 692014Model 2×100T
Identity
- Trade Name
- Collagen Type IV (CIV) eCLIA EUDAMED
- Device Name
- Collagen Type IV (CIV) eCLIA EUDAMED
- Model / Reference
- 50T, EUDAMED692021 EUDAMED100T EUDAMED692013 EUDAMED2×100T EUDAMED692014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341685591 EUDAMED06970341687991 EUDAMED06975984063669 EUDAMED
- Basic UDI-DI
- B-06970341685591 EUDAMEDB-06970341687991 EUDAMEDB-06975984063669 EUDAMED
- EMDN Code
- W0102120199 LIVER FUNCTION - 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
Yes
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
Collagen Type IV (CIV) eCLIA by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06970341685591 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 790d2b20-b1b2-4f96-a45c-de539026ab18 61 fields · synced Jul 13, 2026
- EUDAMED 11c06eb6-1f92-48ff-aed2-c52e600f089b 61 fields · synced May 18, 2026
- EUDAMED b3b76e59-f3ad-44d3-8802-5d9784d9d81f 61 fields · synced May 18, 2026