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Inion FreedomPin Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9281
by Inion Oy
Identity
- Trade Name
- Inion FreedomPin Instruments EUDAMEDFDA UDIInion FreedomPin™ Instruments EUDAMED
- Generic Name
- Bone tack inserter, basic FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion FreedomPin Instruments EUDAMEDApplicator 2.0 mm FDA UDI
- Model / Reference
- INS-9281 EUDAMED1 FDA UDI
- Description
- Applicator 2.0 mm FDA UDI
Identifiers
- Catalog Number
- INS-9281 FDA UDI
- Primary DI / UDI-DI
- 06438408004452 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IRM-INSTRUAF EUDAMEDB-06438408004452 EUDAMED
- Secondary DI
- M224INS92819 EUDAMED
- Direct Marketing DI
- 06438408004452 EUDAMED
- FDA Product Code
- HXJ FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Bone tack inserter, basic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Inion FreedomPin Instruments by Inion Oy — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438408INION-IRM-INSTRUAF | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438408INION-IRM-INSTRUAF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (3)
- EUDAMED 81ccbe57-086f-44c0-ab07-d0da2c2f9957 61 fields · synced Jul 20, 2026
- EUDAMED 2a4cd935-4303-4ffe-964e-790316b7d0f5 61 fields · synced May 19, 2026
- FDA UDI 686420de-b1e2-4ec0-a4ad-bc9c17af0c56 34 fields · synced May 30, 2026