Knitted Ankle Support
by Ersa Med Medi̇kal Ve Ortopedi̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ 5 variants
Ref REF-719-LModel REF-400
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 | Number86825110ER350HL | Date1 Oct 2026 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- Eight Bandage - Elastic
- Model / Reference
- REF-400, REF-719-L
- Primary DI / UDI-DI
- 08682511006577
- Basic UDI-DI
- 86825110ER350HL
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- 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