Orthopedic Walking Boot
by Xiamen LongStar Medical Equipment Co., Ltd 90 variants
Ref FG-W004 MModel FG-4001,FG-4002,FG-4003,FG-4004,FG-4005,FG-4006,FG-4007,FG-4008,FG-4009,FG-4010,FG-4102,FG-4013,FG-4016,FG-4101,FG-4111,FG-4112,FG-PED010,FG-PED011,FG-PED014,FG-PED016,FG-PED017,FG-PED018, etc.
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 | Number697600995OWBVT 06976009950827 | Date7 Jul 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- Withdrawn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
- Orthopedic Walking Boot
- Model / Reference
- FG-4001, FG-4002, FG-4003, FG-4004, FG-4005, FG-4006, FG-4007, FG-4008, FG-4009, FG-4010, FG-4102, FG-4013, FG-4016, FG-4101, FG-4111, FG-4112, FG-PED010, FG-PED011, FG-PED014, FG-PED016, FG-PED017, FG-PED018, etc., FG-W004 M
- Primary DI / UDI-DI
- 06976009950827
- Basic UDI-DI
- 697600995OWBVT
- EMDN Code
- Y090399 Clothes, footwear and covers for prostheses - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000034315
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiamen LongStar Medical Equipment Co., Ltd
See all devices from Xiamen LongStar Medical Equipment 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