Identity
- Trade Name
- Syphon Fr 11/13 L 45cm EUDAMED
- Device Name
- Syphon Fr 11/13 L 45cm EUDAMED
- Model / Reference
- URO 054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05906168942280 EUDAMED
- Basic UDI-DI
- 59061689422URO054L8 EUDAMED
- EMDN Code
- A03010202 UROLOGICAL IRRIGATION CONTROLLERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Syphon Fr 11/13 L 45cm by Calyx Medical Sp. z o.o. — Class IIa — 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 | 59061689422URO054L8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Calyx Medical Sp. z o.o.
- EUDAMED SRN
- PL-MF-000038787
Sources (1)
- EUDAMED 7b2a2750-87e0-4a00-a9dd-df316b27a131 61 fields · synced Jun 19, 2026