Identity
- Trade Name
- EUROSILICONE S.A.S. EUDAMED
- Device Name
- Remote Valve Tissue Expander - Round Shape EUDAMED
- Model / Reference
- ES.12/1100 EUDAMED12/1100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700469707003 EUDAMED
- Basic UDI-DI
- B-03700469707003 EUDAMED
- EMDN Code
- P900105 ROUND TISSUE EXPANDERS 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-03700469707003 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Eurosilicone Sas
- EUDAMED SRN
- FR-MF-000008947
Sources (1)
- EUDAMED 26e6ee81-c96f-4028-a492-186d775e310b 61 fields · synced Jun 19, 2026