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Inion ACL instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9354
by Inion Oy
Identity
- Trade Name
- Inion ACL instrumentation EUDAMEDInion ACL™ Instrumentation FDA UDI
- Generic Name
- Bone lever/elevator, reusable FDA UDI
- Device Name
- Inion ACL instrumentation EUDAMEDInion Instruments EUDAMEDPCL Elevator FDA UDI
- Model / Reference
- INS-9354 EUDAMED1 FDA UDI
- Description
- PCL Elevator FDA UDI
Identifiers
- Catalog Number
- INS-9354 FDA UDI
- Primary DI / UDI-DI
- 06438408002878 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408002878 EUDAMED6438408INION-IRM-INSTRUAF EUDAMED
- Secondary DI
- M224INS935410 EUDAMED
- FDA Product Code
- HTE FDA UDI
- EMDN Code
- L0902 ORTHOPAEDIC SURGERY LEVERS, REUSABLE EUDAMED
- GMDN Term
- Bone lever/elevator, 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
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
Inion ACL 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-06438408002878 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438408002878 | 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 f8f72045-4046-4729-81ca-2297b831d6fc 61 fields · synced Jul 10, 2026
- EUDAMED f27b77ad-f902-4ed5-b1af-992f892e819d 61 fields · synced May 19, 2026
- FDA UDI afbb3e63-60ff-4e7d-8bfb-18a4003f2022 34 fields · synced May 30, 2026