Opia
by Opi̇a İnovasyon Sağlik Medi̇kal Arge Ve Danişmanlik San. Diş Ti̇c. A.Ş. EUDAMED
Active
Ref Op-00201-01 S SIZEModel OP00201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number86836284OP00201N2 | Date12 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- Withdrawn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
- Sterile Single Use Surgical Gown, Opia
- Model / Reference
- OP00201, Op-00201-01 S SIZE
- Primary DI / UDI-DI
- 08683628400005
- Basic UDI-DI
- 86836284OP00201N2
- EMDN Code
- T020401 Standard surgical gowns
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- TR-MF-000021222
Other devices from Opi̇a İnovasyon Sağlik Medi̇kal Arge Ve Danişmanlik San. Diş Ti̇c. A.Ş.
See all devices from Opi̇a İnovasyon Sağlik Medi̇kal Arge Ve Danişmanlik San. Diş Ti̇c. A.Ş. →
Properties
Other properties (12)
- 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