Dětská ortopedická obuv s pevným vedením paty-letní sandálová vycházková
Ref 0032117-004-018, 0032117-005-029, 0032117-005-005, 0032117-001-016, 0032117-005-048, 0032117-001-054, 0032117-002-053, 0032117-005-041, 0032117-002-051, 0032117-001-030, 0032117-006-003, 0032117-002-052, 0032117-003-045, 0032117-003-011, 0032117-005-015, 0032117-001-048, 0032117-004-047, 0032117-003-013, 0032117-003-007, 0032117-004-010, 0032117-003-030, 0032117-003-047, 0032117-004-036, 0032117-005-028, 0032117-004-070, 0032117-002-027, 0032117-004-033, 0032117-002-059, 0032117-004-016, 0032117-001-065, 0032117-006-005, 0032117-003-010, 0032117-005-002, 0032117-003-060, 0032117-006-015, 0032117-004-031, 0032117-003-012, 0032117-005-008, 0032117-001-015, 0032117-003-023, 0032117-003-029, 0032117-004-026, 0032117-005-003, 0032117-002-003, 0032117-005-018, 0032117-005-031, 0032117-004-064, 0032117-002-045, 0032117-003-049, 0032117-002-021, 0032117-003-052
Active
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 | Number859405200111F9 | Date23 Sep 2025 | 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- Withdrawn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
- Dětská ortopedická obuv s pevným vedením paty-letní sandálová vycházková
- Model / Reference
- 0032117-004-018, 0032117-005-029, 0032117-005-005, 0032117-001-016, 0032117-005-048, 0032117-001-054, 0032117-002-053, 0032117-005-041, 0032117-002-051, 0032117-001-030, 0032117-006-003, 0032117-002-052, 0032117-003-045, 0032117-003-011, 0032117-005-015, 0032117-001-048, 0032117-004-047, 0032117-003-013, 0032117-003-007, 0032117-004-010, 0032117-003-030, 0032117-003-047, 0032117-004-036, 0032117-005-028, 0032117-004-070, 0032117-002-027, 0032117-004-033, 0032117-002-059, 0032117-004-016, 0032117-001-065, 0032117-006-005, 0032117-003-010, 0032117-005-002, 0032117-003-060, 0032117-006-015, 0032117-004-031, 0032117-003-012, 0032117-005-008, 0032117-001-015, 0032117-003-023, 0032117-003-029, 0032117-004-026, 0032117-005-003, 0032117-002-003, 0032117-005-018, 0032117-005-031, 0032117-004-064, 0032117-002-045, 0032117-003-049, 0032117-002-021, 0032117-003-052
- Primary DI / UDI-DI
- 08594052002348, 08594052003178, 08594052002935, 08594052000160, 08594052003369, 08594052000542, 08594052001259, 08594052003291, 08594052001235, 08594052000306, 08594052003390, 08594052001242, 08594052001891, 08594052001556, 08594052003031, 08594052000481, 08594052002638, 08594052001570, 08594052001518, 08594052002263, 08594052001747, 08594052001914, 08594052002522, 08594052003161, 08594052002867, 08594052000993, 08594052002492, 08594052001310, 08594052002324, 08594052000658, 08594052003413, 08594052001549, 08594052002904, 08594052002041, 08594052003512, 08594052002478, 08594052001563, 08594052002966, 08594052000153, 08594052001679, 08594052001730, 08594052002423, 08594052002911, 08594052000757, 08594052003062, 08594052003192, 08594052002805, 08594052001174, 08594052001938, 08594052000931, 08594052001969
- Basic UDI-DI
- 859405200111F9
- EMDN Code
- Y063303 Ready-made orthotic shoes
- Device Class
- Class I
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000037146
Other devices from DZO s.r.o.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No