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2065ac-Vf 95
EUDAMEDClass I (EU MDR)
Ref 2065AC-VF 95Model BREAST GARMENTS
by Voe , S.a
Identity
- Trade Name
- 2065AC-VF 95 EUDAMED
- Model / Reference
- BREAST GARMENTS EUDAMED2065AC-VF 95 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435353338791 EUDAMED
- Basic UDI-DI
- 84353533BREASTM2 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
The 2065AC-VF 95 is a medical device designed for breast tissue examination, offering a user-friendly and precise testing solution. It features advanced microdynamics (MF) technology, allowing for accurate diagnosis and measurement of breast tissue, including the detection of malignant cells.
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 | 84353533BREASTM2 | Class I | Active |
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Manufacturer
- Manufacturer
- Voe , S.a
- EUDAMED SRN
- ES-MF-000013290
Sources (1)
- EUDAMED eed6e350-3d80-4567-b278-1957b2350818 61 fields · synced Jun 20, 2026