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Inion ACL instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9341
by Inion Oy
Identity
- Trade Name
- Inion ACL instrumentation EUDAMEDInion ACL™ Instrumentation FDA UDI
- Generic Name
- Ligament graft sizer, noninvasive FDA UDI
- Device Name
- Inion ACL instrumentation EUDAMEDInion Instruments EUDAMEDGraft sizer FDA UDI
- Model / Reference
- INS-9341 EUDAMED1 FDA UDI
- Description
- Graft sizer FDA UDI
Identifiers
- Catalog Number
- INS-9341 FDA UDI
- Primary DI / UDI-DI
- 06438408002830 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408002830 EUDAMED6438408INION-IM-INSTRUM68 EUDAMED
- Secondary DI
- M224INS93419 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Ligament graft sizer, noninvasive 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
Category: Wire holding/twisting forceps
Inion ACL instrumentation by Inion Oy — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-06438408002830 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438408002830 | 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 91ed6edd-439c-4e20-ad87-4a3e0a983d51 61 fields · synced Jun 19, 2026
- EUDAMED efe5c75f-de2b-4aa1-acbb-810ce1f4cfe7 61 fields · synced May 19, 2026
- FDA UDI b1356c83-923e-40e0-af90-6cb75bae19ab 34 fields · synced May 30, 2026