Identity
- Trade Name
- STABIBOOT 3D EUDAMED
- Device Name
- STABIBOOT 3D EUDAMED
- Model / Reference
- STABIBOOT 3D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701459811274 EUDAMED03701459811335 EUDAMED03701459811328 EUDAMED
- Basic UDI-DI
- 37014598PIEG3D001STWJ EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Category: Ankle/foot orthosis
Stabiboot 3d by Groupe Sober Sas — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 37014598PIEG3D001STWJ | Class I | Active |
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Manufacturer
- Manufacturer
- Groupe Sober Sas
- EUDAMED SRN
- FR-MF-000017818
Sources (3)
- EUDAMED 6a4a40c6-4c44-4258-8b85-5afe10c7eba9 61 fields · synced Jul 12, 2026
- EUDAMED 76a79015-7ee1-4071-8c99-7bc606a984dd 61 fields · synced May 19, 2026
- EUDAMED be856310-70f3-430a-8809-cddd6a4fc3c4 61 fields · synced May 19, 2026