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EVO-FIX Jednoczęściowe mocowanie rurki tracheostomijnej
EUDAMEDClass I (EU MDR)
Ref 02002Ref 02003Ref 02001
Identity
- Trade Name
- EVO-FIX Jednoczęściowe mocowanie rurki tracheostomijnej EUDAMED
- Device Name
- EVO-FIX Opaska do mocowania rurek tracheostomijnych EUDAMED
- Model / Reference
- 02002 EUDAMED02003 EUDAMED02001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59037193059696 EUDAMED59037193059900 EUDAMED59037193059382 EUDAMED
- Basic UDI-DI
- 590371931001210029B EUDAMED
- EMDN Code
- R01058001 TRACHEOSTOMIC CANNULAS SUPPORTS 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
EVO-FIX Jednoczęściowe mocowanie rurki tracheostomijnej by Sinmed Spółka Z Ograniczoną Odpowiedzialnością — Class I — MDR — listed in EUDAMED
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 | 590371931001210029B | Class I | Active |
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Manufacturer
- Manufacturer
- Sinmed Spółka Z Ograniczoną Odpowiedzialnością
- EUDAMED SRN
- PL-MF-000002789
Sources (3)
- EUDAMED e00f86f7-d662-40c2-ad7e-047ca760db22 61 fields · synced Oct 6, 2026
- EUDAMED 862aa372-b175-4032-8708-2e19b1e7f49e 61 fields · synced May 18, 2026
- EUDAMED 92e3b5b6-ad1c-4f3b-8303-dc193e89f14f 61 fields · synced May 18, 2026