Identity
- Trade Name
- GUOSTĖ EUDAMED
- Device Name
- Silicone External Breast Prosthesis EUDAMED
- Model / Reference
- Heart E-8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04779043811466 EUDAMED
- Basic UDI-DI
- 477904381EXOBREASTZ3 EUDAMED
- EMDN Code
- Y063018 EXTERNAL BREAST PROSTHESES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
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
Guostė by Pletra Ltd. — Class I — 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 | 477904381EXOBREASTZ3 | Class I | Active |
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Manufacturer
- Manufacturer
- Pletra Ltd.
- EUDAMED SRN
- LT-MF-000004741
Sources (1)
- EUDAMED 57e18bd2-42e9-4a25-b2cf-2dfa32a69d62 61 fields · synced Jul 9, 2026