Infant Radiant Warmer
by Ningbo David Medical Device Co., Ltd. 19 variants
Ref HKN-500AModel HKN-500AB/HKN-500A/HKN-500B/HKN-500/HKN-93C/HKN-93CS
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-06920716303735 | Date7 Sep 2022 | StatusActive |
| European Union | CE/MDD | NumberB-06920716303735 | 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- Withdrawn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
- HKN-500A, HKN-500AB/HKN-500A/HKN-500B/HKN-500/HKN-93C/HKN-93CS
- Primary DI / UDI-DI
- 06920716303735, 06920716305289
- Basic UDI-DI
- B-06920716303735, 69207163HKN-003DD
- Direct Marketing DI
- 06920716305289
- EMDN Code
- Z12080407 Neonatal radiant warmers
- 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