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Alanine Aminotransferase Reagent Kit (Alanine Substrate Method)
EUDAMEDClass B (EU MDR)
Ref /
Identity
- Device Name
- Alanine Aminotransferase Reagent Kit (Alanine Substrate Method) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740733236 EUDAMED06935740740739 EUDAMED06935740711586 EUDAMED
- Basic UDI-DI
- 69357407ICAS000013AP EUDAMED
- EMDN Code
- W01010103 ALANINE 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
Category: Alanine aminotransferase (ALT) IVD, reagent
Alanine Aminotransferase Reagent Kit (Alanine Substrate Method) by URIT Medical Electronic Co., Ltd. — Class B — IVDR — listed in EUDAMED
Similar devices
Also classified as Alanine aminotransferase (ALT) IVD, reagent.
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- ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
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 | 69357407ICAS000013AP | 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 7e8fb3f8-9268-4de6-a402-2bcb17841221 61 fields · synced Oct 6, 2026
- EUDAMED 425d461b-cc4f-4e9f-b0b6-06c4bbcfe1e7 61 fields · synced May 18, 2026
- EUDAMED a11f9667-a4a4-490f-af1e-f670782f9578 61 fields · synced May 18, 2026