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Inion Universal instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9091 Ref INS-9091
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 Universal instrument EUDAMEDInion Instruments EUDAMEDDepth gauge 2.0 mm - 3.1 mm FDA UDI
- Model / Reference
- INS-9091 EUDAMED1 FDA UDI
- Description
- Depth gauge 2.0 mm - 3.1 mm FDA UDI
Identifiers
- Catalog Number
- INS-9091 FDA UDI
- Primary DI / UDI-DI
- 06438408002052 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408002052 EUDAMED6438408INION-IRM-INSTRUAF EUDAMED
- Secondary DI
- M224INS90919 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 — 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-06438408002052 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438408002052 | 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 ef544204-f28c-416d-8f89-a611f886ab9e 61 fields · synced Jul 28, 2026
- EUDAMED a901cf1e-5eed-4ffd-bb99-cc928fd79c24 61 fields · synced May 19, 2026
- FDA UDI 8f8d9579-d9bc-4e5d-a8b1-97a13cc1acc7 34 fields · synced May 30, 2026