Transport Incubator
by Ningbo David Medical Device Co., Ltd. 2 variants
Ref TI-3000A, TI-3000, TI-3000B, TI-2100A, TI-2100B, TI-2000Model TI-3000/TI-3000A/TI-3000B/TI-2100/TI-2100A/TI-2100B
Active
CE MDR CE MDD
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/MDR | NumberB-06920716301793 | Date7 Sep 2022 | StatusActive |
| European Union | CE/MDD | NumberB-06920716301793 | Date7 Sep 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Model / Reference
- TI-3000A, TI-3000/TI-3000A/TI-3000B/TI-2100/TI-2100A/TI-2100B, TI-3000, TI-3000B, TI-2100A, TI-2100B, TI-2000
- Primary DI / UDI-DI
- 06920716301793, 06920716304527, 06920716304541, 06920716301816, 06920716301779, 06920716304534, 06920716301731, 06920716304510, 06920716301755, 06920716305081, 06920716303032, 06920716304503
- Basic UDI-DI
- B-06920716301793, 69207163TI-002CQ, B-06920716301816, B-06920716301779, B-06920716301731, B-06920716301755, 69207163TI-001CN, B-06920716303032
- Direct Marketing DI
- 069207163045270692071630454106920716304534069207163045100692071630508106920716304503
- EMDN Code
- Z1208040302 Mobile neonatal incubators
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000009962
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Ningbo David Medical Device Co., Ltd.
See all devices from Ningbo David Medical Device Co., Ltd. →
Properties
Other properties (12)
- 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
- Incorporates Medicinal Product: No