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Cholyglycine (CG) Test Kit (Latex Immunoturbidimetric)
EUDAMEDClass IVD General (EU MDR)
Ref R1:20mL×4 R2:5mL×4（709）Ref Calibrator：1mL×1（91057）Ref R1:64mL×2 R2:16mL×2（701）Ref R1:20mL×1 R2:5mL×1（702）Ref Quality Control：1mL×1（92048）
Identity
- Trade Name
- Cholyglycine (CG) Test Kit (Latex Immunoturbidimetric) EUDAMED
- Device Name
- Cholyglycine (CG) Test Kit (Latex Immunoturbidimetric) EUDAMED
- Model / Reference
- R1:20mL×4 R2:5mL×4（709） EUDAMEDCalibrator：1mL×1（91057） EUDAMEDR1:64mL×2 R2:16mL×2（701） EUDAMEDR1:20mL×1 R2:5mL×1（702） EUDAMEDQuality Control：1mL×1（92048） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674869740 EUDAMED06971674868149 EUDAMED06971674869733 EUDAMED06971674869757 EUDAMED06971674868514 EUDAMED
- Basic UDI-DI
- B-06971674869740 EUDAMEDB-06971674868149 EUDAMEDB-06971674869733 EUDAMEDB-06971674869757 EUDAMEDB-06971674868514 EUDAMED
- EMDN Code
- W01010202 BILE ACIDS 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Cholyglycine (CG) Test Kit (Latex Immunoturbidimetric) by Biobase Biodustry(Shandong) 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-06971674869740 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (5)
- EUDAMED 22d09b76-f349-4c8d-9fad-d29e10c9124d 61 fields · synced Jul 26, 2026
- EUDAMED ba300a13-7d7a-4bb7-b574-939ad8cc7221 61 fields · synced May 16, 2026
- EUDAMED 5e994b8f-f053-4c37-8c65-08d9d5fdc186 61 fields · synced May 17, 2026
- EUDAMED 965802ed-2f58-4b7a-ba71-e7e6b6f75dea 61 fields · synced May 18, 2026
- EUDAMED 7362b9d3-fc06-430e-9434-dc99a11602a9 61 fields · synced May 18, 2026