Fixation elements
by DINA – HITEX, spol. s r.o. EUDAMED
Active
Ref 78-0101-PModel DinaFix, OP tape
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8591527000500INSQ2 | Date2 Sep 2026 | 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- Withdrawn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
- Model / Reference
- DinaFix, OP tape, 78-0101-P
- Primary DI / UDI-DI
- 08591527014349
- Basic UDI-DI
- 8591527000500INSQ2
- EMDN Code
- M050101 Plasters on spools (rolls)
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CZ-MF-000000312
Other devices from DINA – HITEX, spol. s r.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