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Ortho inserts
EUDAMEDClass I (EU MDR)
Ref IN079001Ref IN079005Ref IN079002Ref IN079004
Identity
- Trade Name
- Ortho inserts EUDAMED
- Device Name
- Ortho inserts EUDAMED
- Model / Reference
- IN079001 EUDAMEDIN079005 EUDAMEDIN079002 EUDAMEDIN079004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976340060087 EUDAMED06976340060124 EUDAMED06976340060094 EUDAMED06976340060117 EUDAMED
- Basic UDI-DI
- 69763400600508G EUDAMED69763400600548Q EUDAMED69763400600518J EUDAMED69763400600538N EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Ortho inserts by Dongguan Jinyang Sporting Goods Co, . Ltd — 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 | 69763400600508G | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Jinyang Sporting Goods Co, . Ltd
- EUDAMED SRN
- CN-MF-000035236
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (4)
- EUDAMED 270e2fff-64f7-4586-9a80-b1aacbac0b1e 61 fields · synced Jul 21, 2026
- EUDAMED 3bb6e121-5b3d-49f8-9620-92bb4d6fe60b 61 fields · synced May 17, 2026
- EUDAMED b444db67-963e-4527-b658-0ad8c9871992 61 fields · synced May 17, 2026
- EUDAMED e2cf5bdd-20b2-4536-8dc4-a22e5704ddfc 61 fields · synced May 18, 2026