Ankle Support
by Yangzhou Jindu Sporting Goods Co., Ltd. EUDAMED
Active
Ref 8090-4Model ADK,CAS4,CAS5,CAS6,CAS7,CAS8,AS10,AS11,AS12,AS13,AS14,AS15,AS16,AS17,AS18,AS19,AS20,AS21,AS22,AS23,AS24,AS25,AS26,AS27,AS28,AS29,AS30,AS31,AS32,AS33,AS34,AS35,AS36,AS37,AS38,AS39,AS40,AS41,AS42,AS43,AS44,AS45,AS46,etc
Overview
An ankle support medical device that provides compression and stability to the ankles, helping to reduce swelling and improve mobility. It is designed for use in various medical settings and can be used for both short-term and long-term management of conditions such as varicose veins, ankle sprains, and post-operative recovery.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69345306AnkleSupport38 | Date23 Jul 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- ADK, CAS4, CAS5, CAS6, CAS7, CAS8, AS10, AS11, AS12, AS13, AS14, AS15, AS16, AS17, AS18, AS19, AS20, AS21, AS22, AS23, AS24, AS25, AS26, AS27, AS28, AS29, AS30, AS31, AS32, AS33, AS34, AS35, AS36, AS37, AS38, AS39, AS40, AS41, AS42, AS43, AS44, AS45, AS46, etc, 8090-4
- Primary DI / UDI-DI
- 06934530608082
- Basic UDI-DI
- 69345306AnkleSupport38
- EMDN Code
- Y090618 Leg and knee protections (including socks for amputated legs)
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000041954
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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