Identity
- Trade Name
- Inion OTPS™ BioRestore EUDAMED
- Device Name
- Inion BioRestore EUDAMED
- Model / Reference
- BRS-1603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438408009624 EUDAMED
- Basic UDI-DI
- B-06438408009624 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Inion OTPS™ BioRestore by Inion Oy — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438408009624 | Class III | Active |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (1)
- EUDAMED e595d082-b108-49f3-ae77-6fc98e17e907 61 fields · synced Jun 17, 2026