all in one monitor
by Nanjing Kaiying Intelligent Medical Technology Co., Ltd 2 variants
Ref 10205008Model AIOS210,AIOS211,AIOS212,AIOS213,AIOS240,AIOS241,AIOS242,AIOS243,AIOS270,AIOS271,AIOS272,AIOS273,AIOS274,AIOS275,AIOS276,PRO270,PRO274,AIOS320,AIOS321
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697737193AIOVN 06977371932701 | Date30 Apr 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- AIOS210, AIOS211, AIOS212, AIOS213, AIOS240, AIOS241, AIOS242, AIOS243, AIOS270, AIOS271, AIOS272, AIOS273, AIOS274, AIOS275, AIOS276, PRO270, PRO274, AIOS320, AIOS321, 10205008
- Primary DI / UDI-DI
- 06977371932701
- Basic UDI-DI
- 697737193AIOVN
- Direct Marketing DI
- 06977371932701
- EMDN Code
- Z11900880 Bioimaging visualization and/or diagnostic report viewing monitors - hardware accessories
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000041141
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Nanjing Kaiying Intelligent Medical Technology Co., Ltd
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No