Identity
- Trade Name
- Bulkamid® Hydrogel EUDAMED
- Device Name
- Bulkamid® Hydrogel EUDAMED
- Model / Reference
- 50009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05704101500098 EUDAMED
- Basic UDI-DI
- 5704101BulkamidCG EUDAMED
- EMDN Code
- U070199 INTERNAL SYSTEMS FOR THE TREATMENT OF INCONTINENCE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
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® Hydrogel 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 | 5704101BulkamidCG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Contura International A/S
- EUDAMED SRN
- DK-MF-000002018
Sources (1)
- EUDAMED 899edffb-9d74-4668-bb22-2bf4fd3c4afc 61 fields · synced Oct 7, 2026