Wkładki ortopedyczne iORTO MEDIC
by Zbigniew Frąckowiak Mazbit Przedsiębiorstwo 47 variants
Ref iORTO DOUBLE KID IO51
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- Withdrawn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
- iORTO DOUBLE KID IO51
- Primary DI / UDI-DI
- 05902574214188, 05902574214119, 05902574214171, 05902574203823, 05902574214140, 05902574214157, 05902574214065, 05902574214133, 05902574203816, 05902574214096, 05902574214126, 05902574214102, 05902574214164, 05902574203793, 05902574214072, 05902574203786, 05902574203809, 05902574214089
- 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