Bunion Orthosis Series
by Medtec International Sdn Bhd 3 variants
Ref MD-HV0001Model MD-HV0001;MD-HV007;MD-VQFO1
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 | Number955102435MEDTECBOSBY 09551024350554 | Date21 Sep 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- Withdrawn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
- Bunion Orthosis Series
- Model / Reference
- MD-HV0001, MD-HV007, MD-VQFO1
- Primary DI / UDI-DI
- 09551024350554
- Basic UDI-DI
- 955102435MEDTECBOSBY
- EMDN Code
- Y061299 Lower extremity orthoses - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- MY-MF-000041112
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Medtec International Sdn Bhd
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