Tubular Toe Protector
by Zhangpu Ortholife Rehabilitation Co., Ltd. 3 variants
Ref 650003(S/UNI/Beige)
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number47198728665WU 04719872866923 | Date28 Apr 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- Withdrawn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
- Insole (Hallux valgus metatarsophalangeal orthosis and toe separator)
- Model / reference
- 650003(S/UNI/Beige)
- Primary DI / UDI-DI
- 04719872866923
- Basic UDI-DI
- 47198728665WU
- EMDN code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000011447
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhangpu Ortholife Rehabilitation Co., Ltd.
See all devices from Zhangpu Ortholife Rehabilitation Co., Ltd. →
Properties
Other properties (14)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No