Πελμα Σιλικονης Ολοκληρο
by Ανατομικ Χελπ Ανωνυμη Εταιρια Εμποριας Και Κατασκευης Ορθοπεδικων Ειδων Α.Ε. 2 variants
Ref 0753
Πελμα Σιλικονης Ολοκληρο (0753) is a Class I device made by Ανατομικ Χελπ Ανωνυμη Εταιρια Εμποριας Και Κατασκευης Ορθοπεδικων Ειδων Α.Ε., registered in EUDAMED on 16 Dec 2021 (Basic UDI-DI 52049140753LK), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number52049140753LK | Date16 Dec 2021 | StatusActive |
Official records
- EUDAMED public site 52049140753LK
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- Withdrawn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
- Πελμα Σιλικονης Ολοκληρο / Silicone Insole Anatomic
- Model / reference
- 0753
- Primary DI / UDI-DI
- 05204914337442, 05204914337466, 05204914337435, 05204914337459, 05204914337473
- Basic UDI-DI
- 52049140753LK
- EMDN code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- GR-MF-000015975
Similar devices in this category
Other devices filed under ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS).
- DUPLO 6073.2 by LABORATORIOS HERBITAS, S.L.
- Aircore™ Offloading Insole ACIP060 by DARCO International, Inc.
- Aircore™ Offloading Insole ACI1 by DARCO International, Inc.
- Soft Stride 71502 by BROWNMED, INC.
- FOOTLOGICS COMFORT PLUS INSOLE XL 1069.4SVP XL by Footlogics Europe B.V.
- ORTESIS HEEL WEDGE 12.719.12 by LABORATORIOS HERBITAS, S.L.
Other devices from Ανατομικ Χελπ Ανωνυμη Εταιρια Εμποριας Και Κατασκευης Ορθοπεδικων Ειδων Α.Ε.
See all devices from Ανατομικ Χελπ Ανωνυμη Εταιρια Εμποριας Και Κατασκευης Ορθοπεδικων Ειδων Α.Ε. →