Identity
- Trade Name
- EUROSILICONE S.A.S. EUDAMED
- Device Name
- Round Gel Filled Mammary Sizers Smooth – Low Profile EUDAMED
- Model / Reference
- ES.35M/220 EUDAMED35M/220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700469709397 EUDAMED
- Basic UDI-DI
- B-03700469709397 EUDAMED
- EMDN Code
- P0699 BREAST IMPLANTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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 IIa — 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-03700469709397 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eurosilicone Sas
- EUDAMED SRN
- FR-MF-000008947
Sources (1)
- EUDAMED bd6d8398-b006-4b93-9e9d-94c4db0624a7 61 fields · synced Jun 18, 2026