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Inion Universal Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9092Ref INS-9092
by Inion Oy
Identity
- Trade Name
- Inion Universal Instruments EUDAMEDInion® Universal instruments FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion Universal instrument EUDAMEDDepth gauge 4.5 mm, cannulated FDA UDI
- Model / Reference
- INS-9092 EUDAMED1 FDA UDI
- Description
- Depth gauge 4.5 mm, cannulated FDA UDI
Identifiers
- Catalog Number
- INS-9092 FDA UDI
- Primary DI / UDI-DI
- 06438408002991 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IRM-INSTRUAF EUDAMEDB-06438408002991 EUDAMED
- Secondary DI
- M224INS90929 EUDAMED
- FDA Product Code
- HTJ FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4300 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 Universal 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 | 6438408INION-IRM-INSTRUAF | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438408INION-IRM-INSTRUAF | 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 6f78817e-4990-4e9c-b43e-2f7f0b548425 61 fields · synced Jun 8, 2026
- EUDAMED 91888ddb-09ab-43be-8556-66dd3df91d08 61 fields · synced May 19, 2026
- FDA UDI ce2582d2-0313-4033-adfe-3ba010b66e75 34 fields · synced May 30, 2026