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FlexiOH
EUDAMEDClass I (EU MDR)
Ref SOS512Ref FAC0XSRef FAC00SRef SOS518Ref SLC00SRef STS00LRef SAC00MRef SAC00LRef FAC00MRef SOS415Ref SOS312Ref SLC0XLRef FAC00LRef SAC0SMRef RGC00LRef LTS00LRef STS00SRef SOS412Ref UGC00LRef UGC00SRef SOS418
Identity
- Trade Name
- FlexiOH EUDAMED
- Device Name
- FlexiOH - Light Cured Polymer Immobilizer EUDAMED
- Model / Reference
- SOS512 EUDAMEDFAC0XS EUDAMEDFAC00S EUDAMEDSOS518 EUDAMEDSLC00S EUDAMEDSTS00L EUDAMEDSAC00M EUDAMEDSAC00L EUDAMEDFAC00M EUDAMEDSOS415 EUDAMEDSOS312 EUDAMEDSLC0XL EUDAMEDFAC00L EUDAMEDSAC0SM EUDAMEDRGC00L EUDAMEDLTS00L EUDAMEDSTS00S EUDAMEDSOS412 EUDAMEDUGC00L EUDAMEDUGC00S EUDAMEDSOS418 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89080147651874 EUDAMED89080147652796 EUDAMED89080147652864 EUDAMED89080147652000 EUDAMED89080147650884 EUDAMED89080147652628 EUDAMED89080147650334 EUDAMED89080147650402 EUDAMED89080147652932 EUDAMED89080147651638 EUDAMED89080147651324 EUDAMED89080147651188 EUDAMED89080147653090 EUDAMED89080147656374 EUDAMED89080147653472 EUDAMED89080147652314 EUDAMED89080147652482 EUDAMED89080147651560 EUDAMED89080147653854 EUDAMED89080147653618 EUDAMED89080147651706 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 (21)
- EUDAMED 995b5cb7-4ca8-47a1-9d7d-4777721ef855 61 fields · synced Sep 18, 2026
- EUDAMED 140eea3f-a0c7-4379-920c-78d67e5d1b96 61 fields · synced May 11, 2026
- EUDAMED 9ae288e8-17ad-46f3-8948-a5a498464347 61 fields · synced May 16, 2026
- EUDAMED ed46770e-3c72-477e-a254-bf7e0ac4e768 61 fields · synced May 16, 2026
- EUDAMED 32b3ef8a-0bfa-43bc-8ad7-14d8bfd59038 61 fields · synced May 16, 2026
- EUDAMED 948e28d9-e280-449c-918c-7704f2c4ea5f 61 fields · synced May 16, 2026
- EUDAMED 612df171-b487-4d9c-9d3d-a5c259d74b5a 61 fields · synced May 17, 2026
- EUDAMED d39eed2b-ee86-464e-86ad-d3659c550af9 61 fields · synced May 17, 2026
- EUDAMED e9fc82b4-fbfe-4f55-9c85-f5cc201e0c24 61 fields · synced May 17, 2026
- EUDAMED e5e41417-0388-4e33-b3e8-255bdb5189dc 61 fields · synced May 18, 2026
- EUDAMED 665b9aea-72e6-409c-8711-1a837ef4b1cd 61 fields · synced May 18, 2026
- EUDAMED f6132c38-8136-4d45-8509-aa5688788689 61 fields · synced May 18, 2026
- EUDAMED 827c8eef-8140-4a8c-a811-5a7df1c7bd8b 61 fields · synced May 18, 2026
- EUDAMED 13220cf7-b48d-4bcd-aad3-d45aeffd5c22 61 fields · synced May 18, 2026
- EUDAMED aea178d4-9bb4-4a32-be02-217111281f9d 61 fields · synced May 18, 2026
- EUDAMED 3f26a4ca-74b3-4feb-ba54-301b84d70d56 61 fields · synced May 18, 2026
- EUDAMED 73e2c7ef-c380-4094-8467-05b1317a8082 61 fields · synced May 18, 2026
- EUDAMED 116287af-7154-4027-ba2a-3c68aa7ba0ae 61 fields · synced May 19, 2026
- EUDAMED 39db0c32-ce48-4972-b6e5-9b34c6a3fa6a 61 fields · synced May 19, 2026
- EUDAMED 848d26d5-b361-482e-858e-e9fe3c2035b7 61 fields · synced May 19, 2026
- EUDAMED 069db20e-93d6-443d-9f84-35ed30cc13e6 61 fields · synced May 19, 2026