Face mask with tie on, Visor TYPE IIR
by Crown Name Disposable Hygiene Products Fty. Ltd.
Ref 481650
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 06973122513113 | 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- Withdrawn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
- 481650
- Primary DI / UDI-DI
- 06973122513113
- Basic UDI-DI
- 697312251FM2007H
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- EU market of registration
- Norway
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