← Back to catalogue
Cholinesterase (CHE) Kit (DGKC Method)
EUDAMEDClass B (EU MDR)
Ref 105-002163-00Model 105-002162-00、105-002163-00、105-002164-00
Identity
- Trade Name
- Cholinesterase (CHE) Kit (DGKC Method) EUDAMED
- Device Name
- Cholinesterase (CHE) Kit (DGKC Method) EUDAMED
- Model / Reference
- 105-002162-00、105-002163-00、105-002164-00 EUDAMED105-002163-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904037448 EUDAMED
- Basic UDI-DI
- 69449040004ECHE********SY 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) Kit (DGKC Method) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69449040004ECHE********SY | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 37bfce88-4826-410d-ae48-3a589d41550d 61 fields · synced Jun 18, 2026