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Total Bile Acid/Cholinesterase/α-Amylase Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref 1Y001
Identity
- Device Name
- Total Bile Acid/Cholinesterase/α-Amylase Reagent Kit EUDAMED
- Model / Reference
- 1Y001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-02B0014YL EUDAMED
- Basic UDI-DI
- B-02B0014YL EUDAMED
- EMDN Code
- W01010111,W01010202 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Total Bile Acid/Cholinesterase/α-Amylase Reagent Kit by Changsha Sinocare Inc. — 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-02B0014YL | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 398e7555-85c0-4396-8b7b-83a2ff7d6974 61 fields · synced Jul 31, 2026