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Inion CPS/OTPS instrumentation
EUDAMEDClass IIa (EU MDR)
Ref INS-9105 Model INS-9105
by Inion Oy
Identity
- Trade Name
- Inion CPS/OTPS instrumentation EUDAMED
- Device Name
- Inion CPS/OTPS instrumentation EUDAMEDInion Instruments EUDAMED
- Model / Reference
- INS-9105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438408001604 EUDAMED
- Basic UDI-DI
- B-06438408001604 EUDAMED6438408INION-IIA-INSTRUUR EUDAMED
- Secondary DI
- M224INS910510 EUDAMED
- EMDN Code
- L098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa 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 CPS/OTPS instrumentation by Inion Oy — Class IIa — 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-06438408001604 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06438408001604 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (2)
- EUDAMED 5048fa81-89e0-4b9a-98e8-8f05c37be9d1 61 fields · synced Jul 11, 2026
- EUDAMED c3b81dec-2f3a-44d2-8dcc-07cd31194966 61 fields · synced May 19, 2026