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Inion Trinion instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9216Ref INS-9215
by Inion Oy
Identity
- Trade Name
- Inion Trinion instruments EUDAMEDInion Trinion™ Instruments FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion Trinion Instruments EUDAMEDScrewdriver handle FDA UDI
- Model / Reference
- INS-9216 EUDAMEDINS-9215 EUDAMED1 FDA UDI
- Description
- Screwdriver handle FDA UDI
Identifiers
- Catalog Number
- INS-9216 FDA UDI
- Primary DI / UDI-DI
- 06438408004674 EUDAMEDFDA UDI06438408004667 EUDAMED
- Basic UDI-DI
- 6438408INIONCLASS1ZE EUDAMEDB-06438408004667 EUDAMED
- Direct Marketing DI
- 06438408004674 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 UDIClass IIa EUDAMED
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMED
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 Trinion instruments by Inion Oy — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438408INIONCLASS1ZE | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438408INIONCLASS1ZE | 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 f92d0803-10f3-46d6-8667-1fffff996f9b 61 fields · synced Jul 24, 2026
- EUDAMED 6536ffd7-4f9d-464e-af58-8a16a569e7f2 61 fields · synced May 19, 2026
- FDA UDI 03ae83ff-44ee-4bc1-be71-9a041bad61a2 35 fields · synced May 30, 2026