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Inion Universal Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9047
by Inion Oy
Identity
- Trade Name
- Inion Universal Instruments EUDAMEDInion® Universal instruments FDA UDI
- Generic Name
- Surgical countersink, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion Universal instrument EUDAMEDCountersink 1.5/2.0 mm FDA UDI
- Model / Reference
- INS-9047 EUDAMED1 FDA UDI
- Description
- Countersink 1.5/2.0 mm FDA UDI
Identifiers
- Catalog Number
- INS-9047 FDA UDI
- Primary DI / UDI-DI
- 06438408000324 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IR-INSTRUM9T EUDAMEDB-06438408000324 EUDAMED
- Secondary DI
- M224INS904710 EUDAMED
- FDA Product Code
- HWW FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical countersink, reusable 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
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 0e7f5898-cbd4-4f03-b020-f246d9c0daa5 61 fields · synced Jul 31, 2026
- EUDAMED c184da2b-544b-4deb-aa50-16bbbc169d84 61 fields · synced May 19, 2026
- FDA UDI 6e745d67-8796-4227-9b1e-b8b62415f130 34 fields · synced May 30, 2026