Identity
- Trade Name
- EUROSILICONE S.A.S EUDAMED
- Device Name
- Round Cristalline Paragel Mammary Implant High Profile EUDAMED
- Model / Reference
- ES.81/500 EUDAMED81/500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700469717149 EUDAMED
- Basic UDI-DI
- B-03700469717149 EUDAMED
- EMDN Code
- P0601010202 BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED 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
Welcome to the EUROSILICONE S.A.S medical device directory. This comprehensive directory provides detailed information about this legacy round crystalline paragel mammary implant high profile device, including its applicable legislation, latest version, and compliance status.
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-03700469717149 | Class III | Active |
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Manufacturer
- Manufacturer
- Eurosilicone Sas
- EUDAMED SRN
- FR-MF-000008947
Sources (1)
- EUDAMED 99acc169-02a9-47b2-8c46-7af918361b6b 61 fields · synced Jul 9, 2026