Identity
- Trade Name
- Bulkamid® Urethral Bulking System EUDAMED
- Device Name
- Bulkamid® Urethral Bulking System EUDAMED
- Model / Reference
- 50012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05704101500128 EUDAMED
- Basic UDI-DI
- 5704101500124Q EUDAMED
- EMDN Code
- U070199 INTERNAL SYSTEMS FOR THE TREATMENT OF INCONTINENCE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Treatment of female urinary incontinence where the stress component is significant. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Bulkamid® Urethral Bulking System by Contura International A/S — Class IIb — 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 | 5704101500124Q | Class IIb | Active |
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Manufacturer
- Manufacturer
- Contura International A/S
- EUDAMED SRN
- DK-PR-000002019
Sources (1)
- EUDAMED 62b82234-8e09-4aae-b08e-2cdb589b21b8 61 fields · synced Oct 6, 2026