Opi̇a
by Opi̇a İnovasyon Sağlik Medi̇kal Arge Ve Danişmanlik San. Diş Ti̇c. A.Ş. 34 variants
Ref OIM(SMS)-0402-04XLModel OIM(SMS)-0402
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 | Number86836284OIM(SMS)0402KK 08683628400524 | Date26 Aug 2022 | 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- Withdrawn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
- Disposable Surgical Overall-Type 3/4
- Model / Reference
- OIM(SMS)-0402, OIM(SMS)-0402-04XL
- Primary DI / UDI-DI
- 08683628400524
- Basic UDI-DI
- 86836284OIM(SMS)0402KK
- EMDN Code
- T020401 Standard surgical gowns
- Device Class
- Class I
- EU 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 (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