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2032b-T 105
EUDAMEDClass I (EU MDR)
Ref 2032B-T 105Model BREAST GARMENTS
by Voe , S.a
Identity
- Trade Name
- 2032B-T 105 EUDAMED
- Model / Reference
- BREAST GARMENTS EUDAMED2032B-T 105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435353337091 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 2032B-T 105 device is a breast garment, designed for women to use as a medical device in the treatment of breast disorders. It features advanced sterility and disinfection capabilities, making it suitable for implantation and use in clinical settings. The device also has built-in diagnostic instruments and is designed with patient comfort and safety in mind.
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 19eff6f8-8c83-455c-a51e-24e822e87e81 61 fields · synced Jul 24, 2026