Identity
- Device Name
- Ustnik do endoskopii EUDAMED
- Model / Reference
- 11002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59037193054714 EUDAMED
- Basic UDI-DI
- 59037193100421003AL EUDAMED
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS 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
Ustnik do endoskopii by Sinmed Spółka Z Ograniczoną Odpowiedzialnością — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 59037193100421003AL | Class I | Active |
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Manufacturer
- Manufacturer
- Sinmed Spółka Z Ograniczoną Odpowiedzialnością
- EUDAMED SRN
- PL-MF-000002789
Sources (1)
- EUDAMED 92b54ac3-ef55-4c46-9c58-6ed2a9f9f329 61 fields · synced Oct 7, 2026