Sani-Dm-03
by Opharm Sp. z o.o. EUDAMED
Active
Ref SANI-DM-03
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number590430208SANIDM03PZ | Date3 Jun 2022 | 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- Withdrawn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
- Device Name
- Sani-Dm-03
- Model / Reference
- SANI-DM-03
- Primary DI / UDI-DI
- 05904302081291, 05904302080850
- Basic UDI-DI
- 590430208SANIDM03PZ
- Direct Marketing DI
- 0590430208129105904302080850
- EMDN Code
- T020604 Medical use face masks, type ii and iir
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000011509
Other devices from Opharm Sp. z o.o.
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