Medical Face Mask
by Shandong Intco Medical Products Co., Ltd. 5 variants
Ref FM301-E50
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 | Number697024575FMYN 06970245751347 | Date5 Dec 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- Withdrawn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
- FM301-E50
- Primary DI / UDI-DI
- 06970245751347
- Basic UDI-DI
- 697024575FMYN
- EMDN Code
- T020603, T020604
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000002100
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Shandong Intco Medical Products Co., Ltd.
See all devices from Shandong Intco Medical Products 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