Identity
- Trade Name
- EUROSILICONE S.A.S. EUDAMED
- Device Name
- Round Paragel Mammary Implant Extra High Profile EUDAMED
- Model / Reference
- ES.281/375 EUDAMED281/375 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700469705320 EUDAMED
- Basic UDI-DI
- B-03700469705320 EUDAMED
- EMDN Code
- P0601010201 BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE EUDAMED
Classification
- Device Class
- Class III 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 III — 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-03700469705320 | Class III | Active |
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Manufacturer
- Manufacturer
- Eurosilicone Sas
- EUDAMED SRN
- FR-MF-000008947
Sources (1)
- EUDAMED 79ce4266-d9d7-446d-8d50-224de9da93f7 61 fields · synced Jun 19, 2026