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Inion Trinion™ instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9214
by Inion Oy
Identity
- Trade Name
- Inion Trinion™ instruments EUDAMEDFDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Inion Trinion instrument EUDAMEDObturator FDA UDI
- Model / Reference
- INS-9214 EUDAMED1 FDA UDI
- Description
- Obturator FDA UDI
Identifiers
- Catalog Number
- INS-9214 FDA UDI
- Primary DI / UDI-DI
- 06438408004650 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408004650 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- Not 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 Trinion™ instruments by Inion Oy — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438408004650 | 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 (2)
- EUDAMED 44366307-6c6b-4a36-b736-401cad883667 61 fields · synced Jul 15, 2026
- FDA UDI be5f5858-5fd2-4c3c-8d36-9ae694bce23e 35 fields · synced May 30, 2026