mask
by Hubei Hongrui Plastics Co., Ltd.
Model mask02, mask01, mask03Ref 01
Active
CE MDR
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 | Number697499997mask025T | Date16 Jun 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- mask
- Model / Reference
- mask02, mask01, 01, mask03
- Primary DI / UDI-DI
- 06974999970009, 06974999970092, 06974999971037, 06974999970016
- Basic UDI-DI
- 697499997mask025T, 697499997MASK017A, 697499997mask035V
- EMDN Code
- T020603, T020604
- Device Class
- Class IClass IIa
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000010781
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hubei Hongrui Plastics 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