Identity
- Trade Name
- Anatomical Gel Filled Mammary Sizers EUDAMED
- Device Name
- Anatomical Gel Filled Mammary Sizers EUDAMED
- Model / Reference
- AS-HR2/245 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700469711598 EUDAMED
- Basic UDI-DI
- 037004697E2012N4 EUDAMED
- Direct Marketing DI
- 03700469711598 EUDAMED
- EMDN Code
- P0699 BREAST IMPLANTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Anatomical Gel Filled Mammary Sizers by Eurosilicone Sas — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 037004697E2012N4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eurosilicone Sas
- EUDAMED SRN
- FR-MF-000008947
Sources (1)
- EUDAMED 8cf1ac6d-a934-4671-9f55-b011c2cc3e6b 61 fields · synced Jun 18, 2026