Ankle / Foot Orthosis
by Fung Lead Medical & Sports Co., Ltd. 9 variants
Ref C503
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 | Number471988344005HW 04719883440228 | Date13 Jun 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- Withdrawn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
- Ankle / Foot Orthosis
- Model / Reference
- C503
- Primary DI / UDI-DI
- 04719883440228
- Basic UDI-DI
- 471988344005HW
- Direct Marketing DI
- 04719883440228
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000012336
- Authorised representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Other devices from Fung Lead Medical & Sports Co., Ltd.
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