Surgical face mask
by Crown Name Disposable Hygiene Products Fty. Ltd. 2 variants
Ref M025
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 | Number697312251FM2007H 06973122513700 | Date31 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- Withdrawn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
- Device Name
- Medical Use Face Masks, Type II and Iir
- Model / Reference
- M025
- Primary DI / UDI-DI
- 06973122513700
- Basic UDI-DI
- 697312251FM2007H
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- Market of Registration
- Finland
Manufacturer details
- EUDAMED SRN
- CN-MF-000008238
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
From the manufacturer
Manufacturer's product page: Face Mask & Headwear
Other devices from Crown Name Disposable Hygiene Products Fty. Ltd.
See all devices from Crown Name Disposable Hygiene Products Fty. 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