Estradiol Calibrators
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Ref 105-004296-00Model 105-004225-00、105-004252-00、105-004296-00
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB74000045C 06944904048376 | Date12 Sep 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Estradiol (CLIA)、Estradiol Calibrators
- Model / Reference
- 105-004225-00、105-004252-00、105-004296-00, 105-004296-00
- Primary DI / UDI-DI
- 06944904048376
- Basic UDI-DI
- 69449040AB74000045C
- EMDN Code
- W0102050103 Estradiol
- Device Class
- Class B
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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Properties
Other properties (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No