Knitted Wrist & Hand Splint
by Ersa Med Medi̇kal Ve Ortopedi̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ 10 variants
Ref REF-722-RIGHT-XXLModel REF-19
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 | Number86825110ER150HA 08682511006799 | Date1 Oct 2026 | 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- Withdrawn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
- Hand & Wrist Splint - Both Sided
- Model / Reference
- REF-19, REF-722-RIGHT-XXL
- Primary DI / UDI-DI
- 08682511006799
- Basic UDI-DI
- 86825110ER150HA
- EMDN Code
- Y060612 Wrist-hand orthoses
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000044533
Other devices from Ersa Med Medi̇kal Ve Ortopedi̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇
See all devices from Ersa Med Medi̇kal Ve Ortopedi̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ →
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