Wkładki ortopedyczne iORTO MEDIC
by Zbigniew Frąckowiak Mazbit Przedsiębiorstwo 47 variants
Ref DYNAMIC SUPPORT (SPACE) IO95
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 | Number59025742IORTO-MEDIC35 | Date25 Apr 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- Withdrawn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
- Model / Reference
- DYNAMIC SUPPORT (SPACE) IO95
- Primary DI / UDI-DI
- 05902574211644, 05902574211491, 05902574211583, 05902574211576, 05902574211484, 05902574211637, 05902574211477, 05902574213464, 05902574211569, 05902574211453, 05902574211408, 05902574211521
- Basic UDI-DI
- 59025742IORTO-MEDIC35
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000039173
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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