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IGO-FIX Dwuczęściowa opaska do mocowania rurek intubacyjnych
EUDAMEDClass I (EU MDR)
Ref 01031Ref 01021Ref 01041
Identity
- Trade Name
- IGO-FIX Dwuczęściowa opaska do mocowania rurek intubacyjnych EUDAMED
- Device Name
- IGO-FIX Opaska do mocowania rurek intubacyjnych EUDAMED
- Model / Reference
- 01031 EUDAMED01021 EUDAMED01041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59037193058606 EUDAMED59037193058460 EUDAMED59037193058842 EUDAMED
- Basic UDI-DI
- 5903719310012100199 EUDAMED
- EMDN Code
- R01038099 ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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
IGO-FIX Dwuczęściowa opaska do mocowania rurek intubacyjnych 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 | 5903719310012100199 | Class I | Active |
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Manufacturer
- Manufacturer
- Sinmed Spółka Z Ograniczoną Odpowiedzialnością
- EUDAMED SRN
- PL-MF-000002789
Sources (3)
- EUDAMED 445719a5-7587-4b98-9000-9b3f5bd827fb 61 fields · synced Oct 6, 2026
- EUDAMED 0b9fb110-a442-4361-aca4-2a7c5f78c252 61 fields · synced May 18, 2026
- EUDAMED af71c24d-90b9-45ee-942a-b98df442d1b0 61 fields · synced May 19, 2026