OP01
by Borch Textile Group A/S 43 variants
Ref OP01
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 | Number5715765OP1H4 | Date22 Aug 2024 | 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- Withdrawn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
- OP01
- Model / Reference
- OP01
- Primary DI / UDI-DI
- 05715765000923, 05715765005317, 05715765003399, 05715765001920, 05715765003047, 05715765003818, 05715765000046, 05715765002361, 05715765004679, 05715765000381, 05715765003757, 05715765002941, 05715765000459, 05715765004969, 05715765005928, 05715765002958, 05715765002514, 05715765002545, 05715765001999, 05715765004860, 05715765001340, 05715765003603
- Basic UDI-DI
- 5715765OP1H4
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- DK-MF-000041570
Other devices from Borch Textile Group A/S
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: 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