← Back to catalogue
Alanine Aminotransferase/Aspartate Aminotransferase/Total Bilirubin/Albumin Rea…
EUDAMEDClass IVD General (EU MDR)
Ref 1F001
Identity
- Device Name
- Alanine Aminotransferase/Aspartate Aminotransferase/Total Bilirubin/Albumin Reagent Kit EUDAMED
- Model / Reference
- 1F001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-02B0004YH EUDAMED
- Basic UDI-DI
- B-02B0004YH EUDAMED
- EMDN Code
- W01010103,W01010110,W01010201,W01010203 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Alanine Aminotransferase/Aspartate Aminotransferase/Total Bilirubin/Albumin Rea… by Changsha Sinocare Inc. — 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-02B0004YH | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 4edde587-f0bd-4f49-b8b2-91e794b4f531 61 fields · synced Oct 6, 2026