Reproductive Multi Control
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Ref 105-031880-00, 105-031883-00, 105-004272-00, 105-008891-00, 105-031881-00, 105-031882-00, 105-004266-00, 105-031884-00, 105-031885-00, 105-004273-00Model 105-031880-00、105-031881-00、105-031882-00、105-031883-00、105-031884-00、105-031885-00, 105-004266-00、105-004272-00、105-008888-00、 105-008890-00、105-004267-00、105-004273-00、105-008889-00、105-008891-00
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 | Number69449040AB74000465U | Date17 Dec 2024 | 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- Withdrawn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
- Model / Reference
- 105-031880-00、105-031881-00、105-031882-00、105-031883-00、105-031884-00、105-031885-00, 105-031880-00, 105-031883-00, 105-004266-00、105-004272-00、105-008888-00、 105-008890-00、105-004267-00、105-004273-00、105-008889-00、105-008891-00, 105-004272-00, 105-008891-00, 105-031881-00, 105-031882-00, 105-004266-00, 105-031884-00, 105-031885-00, 105-004273-00
- Primary DI / UDI-DI
- 06903053045742, 06903053045773, 06944904048147, 06936415908041, 06903053045759, 06903053045766, 06944904048086, 06903053045780, 06903053045797, 06944904048154
- Basic UDI-DI
- 69449040AB74000465U, 69449040004H-RM-Con****NJ
- Direct Marketing DI
- 069030530457420690305304577306903053045759069030530457660690305304578006903053045797
- EMDN Code
- W01021521 Multicomponent immunochemistry controls
- Device Class
- Class BClass C
- EU 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
Other properties (8)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No