Softex
by Medicom SAS EUDAMED
Active
Ref M14311-30, M95121-30, M14301-30, M14311-30-LP, M35511-30, M35111V-30, M35211-30, M14321-30
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number37014074MAII146R | Date5 Feb 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Medical Face Mask TIIMedical Face Mask TIIR
- Model / Reference
- M14311-30, M95121-30, M14301-30, M14311-30-LP, M35511-30, M35111V-30, M35211-30, M14321-30
- Primary DI / UDI-DI
- 03662036012203, 03662036012753, 03662036012180, 03662036019196, 03662036020192, 03662036013774, 03662036013156, 03662036012227
- Basic UDI-DI
- 37014074MAII146R, 37014074MAIIR15AJ
- EMDN Code
- T020604 Medical use face masks, type ii and iir
- Device Class
- Class I
- Market of Registration
- FranceBelgium
Manufacturer details
- EUDAMED SRN
- FR-MF-000002873
Other devices from Medicom SAS
Properties
Show properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No