Identity
- Trade Name
- Inion S-1™ Instrumentation EUDAMEDInion S-1 Instrumentation EUDAMED
- Device Name
- Inion S-1 Instruments EUDAMEDInion Instruments EUDAMED
- Model / Reference
- INS-9558 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438408005060 EUDAMED
- Basic UDI-DI
- B-06438408005060 EUDAMED6438408INION-IR-INSTRUM9T EUDAMED
- Secondary DI
- M224INS955810 EUDAMED
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Inion S-1™ Instrumentation by Inion Oy — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438408005060 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438408005060 | Class I | Active |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (2)
- EUDAMED 3a425d00-64f8-4a4d-8422-175dc436f31d 61 fields · synced Jun 19, 2026
- EUDAMED dcc155e2-3f7e-4ba0-be5c-5182fd3f7b3e 61 fields · synced May 17, 2026