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Cholylglycine (CG) eCLIA
EUDAMEDClass IVD General (EU MDR)
Ref 692016Model 2×100TRef 692023Model 50TRef 692015Model 100TRef 692024Model 2×50T
Identity
- Trade Name
- Cholylglycine (CG) eCLIA EUDAMED
- Device Name
- Cholylglycine (CG) eCLIA EUDAMED
- Model / Reference
- 2×100T EUDAMED692016 EUDAMED50T EUDAMED692023 EUDAMED100T EUDAMED692015 EUDAMED2×50T EUDAMED692024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063652 EUDAMED06970341685614 EUDAMED06970341688004 EUDAMED06970341685621 EUDAMED
- Basic UDI-DI
- B-06975984063652 EUDAMEDB-06970341685614 EUDAMEDB-06970341688004 EUDAMEDB-06970341685621 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
Cholylglycine (CG) 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-06975984063652 | 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 (4)
- EUDAMED d0572347-db42-417d-8c69-c2e4ab26719d 61 fields · synced Jul 26, 2026
- EUDAMED 449b832b-8bd2-4aa4-815b-ad96167bf625 61 fields · synced May 17, 2026
- EUDAMED 5db908fd-7cb9-41e8-b96e-f986d4420ad0 61 fields · synced May 17, 2026
- EUDAMED a987cf73-b4ff-446a-af50-3f8496d16dc0 61 fields · synced May 17, 2026