Ankle external brace
by Xiamen Huakang Orthopedic Co., Ltd 20 variants
Ref AS001Model AS001 AS002 AS003 AS004 AS005 AS006 AS007 AS008 AS009 AS010 AS011 AS012 AS013 AS015 AS016 AS017 AS018 AS019 AS020
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697581676AEB001GY 06975816761893 | Date16 Jun 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ankle external brace
- Model / Reference
- AS001 AS002 AS003 AS004 AS005 AS006 AS007 AS008 AS009 AS010 AS011 AS012 AS013 AS015 AS016 AS017 AS018 AS019 AS020, AS001
- Primary DI / UDI-DI
- 06975816761893
- Basic UDI-DI
- 697581676AEB001GY
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000002290
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiamen Huakang Orthopedic Co., Ltd
Properties
Other properties (12)
- Sterile: No
- Implantable: 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