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Inion Universal Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9068
by Inion Oy
Identity
- Trade Name
- Inion Universal Instruments EUDAMEDInion® Universal instruments FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion Universal instrument EUDAMEDDrill guide FDA UDI
- Model / Reference
- INS-9068 EUDAMED1 FDA UDI
- Description
- Drill guide FDA UDI
Identifiers
- Catalog Number
- INS-9068 FDA UDI
- Primary DI / UDI-DI
- 06438408002045 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IR-INSTRUM9T EUDAMEDB-06438408002045 EUDAMED
- Secondary DI
- M224INS90689 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 Universal 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-IR-INSTRUM9T | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438408INION-IR-INSTRUM9T | 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 a5bd5c8d-96e6-4e1c-9c12-17b030a3da4c 61 fields · synced Jul 9, 2026
- EUDAMED f61b88d2-0e5c-4797-8b6a-fca7ad6826c0 61 fields · synced May 18, 2026
- FDA UDI 93f21e3d-3d8e-48de-82cc-015dcfd76257 34 fields · synced May 30, 2026