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Aspartate Aminotransferase Reagent Kit (Aspartic Acid Substrate Method)
EUDAMEDClass B (EU MDR)
Ref /
Identity
- Device Name
- Aspartate Aminotransferase Reagent Kit (Aspartic Acid Substrate Method) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740733243 EUDAMED06935740739252 EUDAMED06935740711609 EUDAMED
- Basic UDI-DI
- 69357407ICAS000017AX EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class B 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
New Device
No
EUDAMED
Aspartate Aminotransferase Reagent Kit (Aspartic Acid Substrate Method) by URIT Medical Electronic Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69357407ICAS000017AX | Class B | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED e7b62d07-6a61-4e7b-ae3e-23237ef0d0fb 61 fields · synced Oct 6, 2026
- EUDAMED b55d1986-a1c2-4342-96aa-1f1ae7902271 61 fields · synced May 17, 2026
- EUDAMED bd7b7aba-f525-45dc-940c-091117039974 61 fields · synced May 19, 2026