ΣΤΗΡΙΓΜΑ ΚΑΡΠΟΥ & ΑΝΤΙΧΕΙΡΑ Neo ONE SIZE
by Ανατομικ Χελπ Ανωνυμη Εταιρια Εμποριας Και Κατασκευης Ορθοπεδικων Ειδων Α.Ε.
Ref 0553
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 | Number52049140553L9 05204914380530 | Date13 Jan 2022 | 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- Withdrawn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
- ΣΤΗΡΙΓΜΑ ΚΑΡΠΟΥ & ΑΝΤΙΧΕΙΡΑ Neo ONE SIZE / WRIST & THUMB BRACE ONE SIZE
- Model / Reference
- 0553
- Primary DI / UDI-DI
- 05204914380530
- Basic UDI-DI
- 52049140553L9
- EMDN Code
- Y060609 Wrist (forearm) orthoses
- Device Class
- Class I
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- GR-MF-000015975
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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