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Inion S-1 Instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9555
by Inion Oy
Identity
- Trade Name
- Inion S-1 Instrumentation EUDAMEDInion S-1™ Instrumentation EUDAMEDInion SPINE instrumentation FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Inion Instruments EUDAMEDInion S-1 Instruments EUDAMEDDrill guide, twin FDA UDI
- Model / Reference
- INS-9555 EUDAMED1 FDA UDI
- Description
- Drill guide, twin FDA UDI
Identifiers
- Catalog Number
- INS-9555 FDA UDI
- Primary DI / UDI-DI
- 06438408005046 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IR-INSTRUM9T EUDAMEDB-06438408005046 EUDAMED
- Secondary DI
- M224INS95559 EUDAMED
- Direct Marketing DI
- 06438408005046 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical drill guide, reusable 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 S-1 Instrumentation 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-IR-INSTRUM9T | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438408INION-IR-INSTRUM9T | 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 (4)
- EUDAMED 5bba2aab-f3b9-4603-94e4-d1a2512ce9c6 61 fields · synced Jul 13, 2026
- EUDAMED 89f509da-fe42-4f4a-aee6-aaed89833f1b 61 fields · synced May 19, 2026
- FDA UDI 6834484d-218a-413e-a258-a6a5c2e1eb94 34 fields · synced May 30, 2026
- EUDAMED b8c12ea4-fc13-41b4-a692-903c0ef78799 61 fields · synced Jun 14, 2026