Face masks
by Shaoxing Yibon Medical Co., Ltd. 7 variants
Ref T329101LIME, 4128102, T329101BL, 400001, T329101GN, 4120004, 4120002Model I
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 | Number6972370764100000MV | Date24 Dec 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- Withdrawn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
- I, T329101LIME, 4128102, T329101BL, 400001, T329101GN, 4120004, 4120002
- Primary DI / UDI-DI
- 06937437814716, 06937437814402, 06937437814693, 06972370768825, 06937437812644, 06937437814129, 06937437812163
- Basic UDI-DI
- 6972370764100000MV
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- EU market of registration
- GermanySwedenBelgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000003378
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Shaoxing Yibon 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