Identity
- Trade Name
- Bulkamid® Rotatable Sheath EUDAMED
- Device Name
- Bulkamid® Rotatable Sheath EUDAMED
- Model / Reference
- 10047 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05704101100472 EUDAMED
- Basic UDI-DI
- 5704101BURSY8 EUDAMED
- EMDN Code
- U0780 DEVICES FOR THE TREATMENT OF INCONTINENCE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Bulkamid® Rotatable Sheath by Contura International A/S — 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 | 5704101BURSY8 | Class I | Active |
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Manufacturer
- Manufacturer
- Contura International A/S
- EUDAMED SRN
- DK-MF-000002018
Sources (1)
- EUDAMED c2718146-aceb-4aaa-b0f3-cb0f60767535 61 fields · synced Oct 6, 2026