Identity
- Trade Name
- IS-01 EUDAMED
- Device Name
- System integracji OPERA EUDAMED
- Model / Reference
- IS-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904384698011 EUDAMED
- Basic UDI-DI
- 5904384698IS01OPERAME EUDAMED
- Direct Marketing DI
- 05904384698011 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
Category: Device sterilization/disinfection container, reusable
Is-01 by Infimed Spółka z ograniczona odpowiedzialnością — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5904384698IS01OPERAME | Class I | Active |
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Manufacturer
- Manufacturer
- Infimed Spółka z ograniczona odpowiedzialnością
- EUDAMED SRN
- PL-MF-000015633
Sources (1)
- EUDAMED 598bb9e2-2f70-4b7d-aac9-d9f0b7fe60a6 61 fields · synced Jun 19, 2026