Resuscitation Mask
by Xiamen Tianzuo Medical Co., Ltd. 8 variants
Ref TW8340
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 | Number69703857234CPR9Z 06970385724003 | Date7 Mar 2023 | 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- Withdrawn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
- TW8340
- Primary DI / UDI-DI
- 06970385724003
- Basic UDI-DI
- 69703857234CPR9Z
- EMDN Code
- R03010199 Ventilation masks - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000018733
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Xiamen Tianzuo Medical 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