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Alanine Aminotransferase & Aspartate Aminotransferase Dry Chemistry Kit
EUDAMEDClass IVD General (EU MDR)
Ref DC2211YModel 20 test
Identity
- Trade Name
- Alanine Aminotransferase & Aspartate Aminotransferase Dry Chemistry Kit EUDAMED
- Device Name
- Alanine Aminotransferase & Aspartate Aminotransferase Dry Chemistry Kit EUDAMED
- Model / Reference
- 20 test EUDAMEDDC2211Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595752311 EUDAMED
- Basic UDI-DI
- B-06936595752311 EUDAMED
- EMDN Code
- W0101060109 MULTIPLE PARAMETER BLOOD TEST EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Alanine Aminotransferase & Aspartate Aminotransferase Dry Chemistry Kit by Medicalsystem Biotechnology 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-06936595752311 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 9ed20eba-beaf-43ce-af19-2a28d2f1bcee 61 fields · synced Aug 2, 2026