Insoles for diabetics
by diawin Deutschland GmbH 16 variants
Ref DI11422, DII11362, DI11473, DI11483, DI11402, DI11453, DI11361, DI11371, DI11401, DI11373, DI11452, DI11353, DI11382, DI11391, DI11403, DI11413, DI11431, DI11481, DI11412, DI11352, DI11471, DI11441, DI11411, DI11472, DI11392
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08586022884832 | Date4 Nov 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- Withdrawn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/MDD Active
Specification
- Device Name
- Insoles for diabetics
- Model / Reference
- DI11422, DII11362, DI11473, DI11483, DI11402, DI11453, DI11361, DI11371, DI11401, DI11373, DI11452, DI11353, DI11382, DI11391, DI11403, DI11413, DI11431, DI11481, DI11412, DI11352, DI11471, DI11441, DI11411, DI11472, DI11392
- Primary DI / UDI-DI
- 08586022884832, 08586022884658, 08586022884993, 08586022885020, 08586022884771, 08586022884931, 08586022884641, 08586022884665, 08586022884757, 08586022884696, 08586022884924, 08586022884634, 08586022884719, 08586022884733, 08586022884788, 08586022884818, 08586022884856, 08586022885006, 08586022884801, 08586022884627, 08586022884979, 08586022884887, 08586022884795, 08586022884986, 08586022884740
- Basic UDI-DI
- B-08586022884832, B-08586022884658, B-08586022884993, B-08586022885020, B-08586022884771, B-08586022884931, B-08586022884641, B-08586022884665, B-08586022884757, B-08586022884696, B-08586022884924, B-08586022884634, B-08586022884719, B-08586022884733, B-08586022884788, B-08586022884818, B-08586022884856, B-08586022885006, B-08586022884801, B-08586022884627, B-08586022884979, B-08586022884887, B-08586022884795, B-08586022884986, B-08586022884740
- EMDN Code
- Y063303 Ready-made orthotic shoes
- Device Class
- Class I
- EU market of registration
- Slovakia
Manufacturer details
- EUDAMED SRN
- DE-MF-000040108
Other devices from diawin Deutschland GmbH
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No