Op Air
by Medicom SAS EUDAMED
Active
Ref M21101M-30, M24101M-30, M31201-30, M34101MNV-30, M34101MV-30, M37101-30, M24101MN-30, M34101MN-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- Withdrawn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
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Trade Name
- Op AirOp Air One
- Device Name
- Medical Face Mask TIIMedical Face Mask TIIR
- Model / Reference
- M21101M-30, M24101M-30, M31201-30, M34101MNV-30, M34101MV-30, M37101-30, M24101MN-30, M34101MN-30
- Primary DI / UDI-DI
- 03662036012418, 03662036012531, 03662036012791, 03662036013484, 03662036013507, 03662036013293, 03662036013811, 03662036013460
- Basic UDI-DI
- 37014074MAII146R, 37014074MAII166V, 37014074MAIIR15AJ, 37014074MAIIR11AA
- EMDN Code
- T020604 Medical use face masks, type ii and iir
- Device Class
- Class I
- Market of Registration
- FrancePortugal
Manufacturer details
- EUDAMED SRN
- FR-MF-000002873
Other devices from Medicom SAS
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