Identity
- Trade Name
- FlexiOH EUDAMED
- Device Name
- FlexiOH - Light Cured Polymer Immobilizer EUDAMED
- Model / Reference
- SOS309 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89080147651256 EUDAMED
- Basic UDI-DI
- 8908014765FLXFY EUDAMED
- EMDN Code
- M030599 IMMOBILISATION SYSTEMS AND DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
FlexiOH by Jc Orthoheal Private Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8908014765FLXFY | Class I | Active |
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Manufacturer
- Manufacturer
- Jc Orthoheal Private Limited
- EUDAMED SRN
- IN-MF-000026318
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED 86eb948e-b054-4181-8f2a-67017f00a7c6 61 fields · synced May 21, 2026