Orthopedic footwear for diabetics
by diawin Deutschland GmbH 7 variants
Ref AM30373, AM30363, AM30381, AM30393, AM30383Model Smooth Jazz 37 extra wide, Smooth Jazz 36 extra wide, Smooth Jazz 38 medium, Smooth Jazz 39 wide, Smooth Jazz 38 extra wide, Smooth Jazz 39 extra wide
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 | Number858602288AM303738Y | Date15 Jul 2024 | 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- Withdrawn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 footwear for diabetics
- Model / Reference
- Smooth Jazz 37 extra wide, AM30373, Smooth Jazz 36 extra wide, AM30363, Smooth Jazz 38 medium, AM30381, Smooth Jazz 39 wide, AM30393, Smooth Jazz 38 extra wide, AM30383, Smooth Jazz 39 extra wide
- Primary DI / UDI-DI
- 08586022882838, 08586022882807, 08586022882845, 08586022882883, 08586022882869, 08586022882890
- Basic UDI-DI
- 858602288AM303738Y, 858602288AM303638V, 858602288AM303818X, 858602288AM3039294, 858602288AM3038393, 858602288AM3039396
- EMDN Code
- Y063303 Ready-made orthotic shoes
- Device Class
- Class I
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- DE-MF-000040108
Other devices from diawin Deutschland GmbH
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