ACE Calibrator
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-002313-00Model 105-006179-00、105-002248-00、105-002249-00、105-006180-00、105-004509-00、105-004510-00、105-002313-00、105-002314-00
EMDN W0101050201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040004JACE********SA | Date19 Jul 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Angiotensin Converting Enzyme Kit (Enzymatic Colorimetric Assay Method)、ACE Calibrator、 ACE Control
- Model / Reference
- 105-006179-00、105-002248-00、105-002249-00、105-006180-00、105-004509-00、105-004510-00、105-002313-00、105-002314-00, 105-002313-00
- Primary DI / UDI-DI
- 06944904032351
- Basic UDI-DI
- 69449040004JACE********SA
- EMDN Code
- W0101050201 Enzyme controls
- Device Class
- Class B
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 0fd24512-ef71-46c8-8e73-b9abd707afd4