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Urology
EUDAMEDClass IIa (EU MDR)
Ref SYN-URO02-001Model URO 02Ref SYN-URO01-001Model URO 01
Identity
- Trade Name
- Urology EUDAMED
- Device Name
- URO (Urology) EUDAMED
- Model / Reference
- URO 02 EUDAMEDSYN-URO02-001 EUDAMEDURO 01 EUDAMEDSYN-URO01-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065021834077 EUDAMED05065021834282 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP007ZD EUDAMED5065021834SYNPP028ZM EUDAMED
- EMDN Code
- U0399 DEVICES FOR URINARY TRACT DILATION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Medical Purpose
- Supports surgeries of the urinary system, offering sterile tools for urological interventions. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Urology by SYNDEO Medical — 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 | 5065021834SYNPP007ZD | Class IIa | Active |
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Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (2)
- EUDAMED 47f4b6a4-f6eb-4f10-bb2e-f200d5c2652b 61 fields · synced Jul 9, 2026
- EUDAMED f87fd373-c298-4699-aab3-55d763b4954d 61 fields · synced May 18, 2026