Identity
- Trade Name
- Syphon Fr 11/13 L 35cm EUDAMED
- Device Name
- SYPHON (FR 11/13) L 35cm EUDAMED
- Model / Reference
- URO 053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05906168942273 EUDAMED
- Basic UDI-DI
- 59061689422URO053L6 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 35cm 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 | 59061689422URO053L6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Calyx Medical Sp. z o.o.
- EUDAMED SRN
- PL-MF-000038787
Sources (1)
- EUDAMED e0618167-72ac-4593-8f83-7c1018bb3221 61 fields · synced Jun 18, 2026