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Inion Universal instruments
EUDAMEDClass I (EU MDR)
Ref ACC-9802Ref ACC-9802
by Inion Oy
Identity
- Trade Name
- Inion Universal instruments EUDAMED
- Device Name
- Inion Universal instrument EUDAMED
- Model / Reference
- ACC-9802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438408000348 EUDAMED
- Basic UDI-DI
- 6438408INIONTHERMODRAPEK6 EUDAMEDB-06438408000348 EUDAMED
- Secondary DI
- M224ACC980210 EUDAMED
- EMDN Code
- T020103 SURGICAL THERMAL DRAPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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 Universal instruments by Inion Oy — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438408INIONTHERMODRAPEK6 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438408INIONTHERMODRAPEK6 | Class I | Active |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (2)
- EUDAMED 222b63fe-94dd-4caa-9f54-f2e965b0970f 61 fields · synced Jul 10, 2026
- EUDAMED fa6d07f2-6a16-473a-a5eb-18755ba7e49b 61 fields · synced May 19, 2026