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Inion FreedomScrew instrumentation
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IFS-9801
by Inion Oy
Identity
- Trade Name
- Inion FreedomScrew instrumentation EUDAMEDInion FreedomScrew instruments FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Inion FreedomScrew instrumentation EUDAMEDInion Instruments EUDAMEDInstrument tray FDA UDI
- Model / Reference
- IFS-9801 EUDAMED1 FDA UDI
- Description
- Instrument tray FDA UDI
Identifiers
- Catalog Number
- IFS-9801 FDA UDI
- Primary DI / UDI-DI
- 06438408004117 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408004117 EUDAMED6438408INIONCLASS1ZE EUDAMED
- Direct Marketing DI
- 06438408004117 EUDAMED
- FDA Product Code
- OJH FDA UDI
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass 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 FreedomScrew instrumentation by Inion Oy — Class IIa — 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-06438408004117 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06438408004117 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (3)
- EUDAMED 721d8903-297d-434d-901c-2a6ad79c5719 61 fields · synced Jul 20, 2026
- EUDAMED 487d132b-cb92-4c13-a922-a44d03de5865 61 fields · synced May 19, 2026
- FDA UDI 24b30594-1f21-4c52-9cee-128069b82851 34 fields · synced May 29, 2026