Hip Fix 2015, Bariatric, Upgrade System. For single use pads, 2015-50-1
Ref 2015-100+8
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 | Number0571483400100TG 05714834001311 | Date6 Dec 2023 | 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- Withdrawn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
- Hip Fix 2000, Complete lateral positioning system w/fixed pads
- Model / Reference
- 2015-100+8
- Primary DI / UDI-DI
- 05714834001311
- Basic UDI-DI
- 0571483400100TG
- Direct Marketing DI
- 05714834001311
- EMDN Code
- Z12011299 Patient positioning instruments – other
- Device Class
- Class I
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- DK-MF-000001594
Other devices from Opitek International
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