Identity
- Trade Name
- Inion BioRestore™ EUDAMEDInion BioRestore™ FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Inion BioRestore EUDAMEDOval 6 mm FDA UDI
- Model / Reference
- BRS-5412 EUDAMED1 FDA UDI
- Description
- Oval 6 mm FDA UDI
Identifiers
- Catalog Number
- BRS-5412 FDA UDI
- Primary DI / UDI-DI
- 06438408008979 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408008979 EUDAMED
- 510(k) Number
- K070998 FDA UDI
- FDA Product Code
- MQV FDA UDI
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Inion BioRestore™ by Inion Oy — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438408008979 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (2)
- EUDAMED 12e6b3bf-5191-48ab-ad93-a52d0375fa2a 61 fields · synced Jul 9, 2026
- FDA UDI f28fa086-2de9-4a59-8099-1cdf9f22b0ea 35 fields · synced May 30, 2026