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Cholinesterase (CHE) Test Kit (Butyryl Thiocholine Substrate Method)
EUDAMEDClass B (EU MDR)
Ref /
Identity
- Device Name
- Cholinesterase (CHE) Test Kit (Butyryl Thiocholine Substrate Method) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740712743 EUDAMED06935740712767 EUDAMED06935740740715 EUDAMED06935740739207 EUDAMED
- Basic UDI-DI
- 69357407ICAS000026AY EUDAMED
- EMDN Code
- W01010111 CHOLINESTERASE 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
Cholinesterase (CHE) Test Kit (Butyryl Thiocholine 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 | 69357407ICAS000026AY | 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 (4)
- EUDAMED 659781c0-9411-4bdc-a9b5-aebe58b76254 61 fields · synced Oct 6, 2026
- EUDAMED 071c1e3c-51ec-452c-ab36-df8567132295 61 fields · synced May 18, 2026
- EUDAMED 340c6157-f572-4925-a4ec-c69c95253ee9 61 fields · synced May 18, 2026
- EUDAMED 1d032811-cb89-4988-b18e-e186d2f648ce 61 fields · synced May 18, 2026