← Back to catalogue
Inion Universal instrument
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9024
by Inion Oy
Identity
- Trade Name
- Inion Universal instrument EUDAMEDInion® Universal instruments FDA UDI
- Generic Name
- Bone fixation plate pliers FDA UDI
- Device Name
- Inion Instruments EUDAMEDPlate bending pliers FDA UDI
- Model / Reference
- INS-9024 EUDAMED1 FDA UDI
- Description
- Plate bending pliers FDA UDI
Identifiers
- Catalog Number
- INS-9024 FDA UDI
- Primary DI / UDI-DI
- 06438408000317 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INIONCLASS1ZE EUDAMED
- Direct Marketing DI
- 06438408000317 EUDAMED
- FDA Product Code
- HTC FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Bone fixation plate pliers 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 instrument by Inion Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438408INIONCLASS1ZE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (2)
- EUDAMED bc8e7e4f-85f4-46fd-ba99-4e8f46d773fa 61 fields · synced Jul 16, 2026
- FDA UDI 39b60c81-e062-45ce-89f0-0ec1e43664b9 34 fields · synced May 30, 2026