Identity
- Trade Name
- Pure fresh EUDAMED
- Device Name
- Breast prostheses, external EUDAMED
- Model / Reference
- 1086X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058509405235 EUDAMED
- Basic UDI-DI
- 4009706Y06301801XR EUDAMED
- Direct Marketing DI
- 04058509405235 EUDAMED
- EMDN Code
- Y063018 EXTERNAL BREAST PROSTHESES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Pure fresh by Anita Dr. Helbig GmbH — 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 | 4009706Y06301801XR | Class I | Active |
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Manufacturer
- Manufacturer
- Anita Dr. Helbig GmbH
- EUDAMED SRN
- DE-MF-000012631
Sources (1)
- EUDAMED c12f6a74-b50c-4638-9d0e-16a4c1472cb3 61 fields · synced Sep 18, 2026