Identity
- Trade Name
- EUROSILICONE S.A.S. EUDAMED
- Device Name
- Testicular Implant EUDAMED
- Model / Reference
- ES.520/12 EUDAMED520/12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700469707911 EUDAMED
- Basic UDI-DI
- B-03700469707911 EUDAMED
- EMDN Code
- P080201 TESTICLE PROSTHESES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Eurosilicone S.a.s. by Eurosilicone Sas — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03700469707911 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Eurosilicone Sas
- EUDAMED SRN
- FR-MF-000008947
Sources (1)
- EUDAMED a1b09de4-e5ab-46a8-b46f-37d692ce4f7a 61 fields · synced Jun 18, 2026