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Inion CompressOn screw instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref IFS-9025
by Inion Oy
Identity
- Trade Name
- Inion CompressOn screw instrumentation EUDAMEDInion CompressOn™ Instrument FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Inion CompressOn Screw instrumentation EUDAMEDInion Instruments EUDAMEDDrill sleeve Ø3.7/5.0 mm, for Ø 5.0 mm screws FDA UDI
- Model / Reference
- IFS-9025 EUDAMED1 FDA UDI
- Description
- Drill sleeve Ø3.7/5.0 mm, for Ø 5.0 mm screws FDA UDI
Identifiers
- Catalog Number
- IFS-9025 FDA UDI
- Primary DI / UDI-DI
- 06438408008108 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408008108 EUDAMED6438408INION-IR-INSTRUM9T EUDAMED
- Direct Marketing DI
- 06438408008108 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
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
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 CompressOn screw instrumentation by Inion Oy — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438408008108 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438408008108 | 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 (4)
- EUDAMED a1a5a795-6056-4a9c-8631-3c8a914d669c 61 fields · synced Sep 17, 2026
- EUDAMED 5dd7b582-6ac7-44b3-81b0-397bbd6190f3 61 fields · synced May 18, 2026
- FDA UDI 1932350b-1649-43d7-b6c2-5892f4efdad5 34 fields · synced May 30, 2026
- EUDAMED 6a6bb3ba-b724-4eca-a11c-7386c79d9b94 61 fields · synced Jun 18, 2026