Bra for Breast Prosthesis
by Ortho Pauher Industria Comercio E Distribuicoes Ltda 2 variants
Ref SG437
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number789994730026R | Date24 Jun 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- External Breast Prosthesis
- Model / Reference
- SG437
- Primary DI / UDI-DI
- 07899947302284, 07898529513841, 07899947302222, 07899947326600, 07899947326631, 07899947326655, 07899947326617, 07899947302215, 07899947302253, 07898529513780, 07898529513810, 07898529513865, 07898529513797, 07899947326594, 07898529513803, 07899947302291, 07899947302260, 07899947302277, 07899947305896, 07898529513858, 07899947302239, 07899947326624, 07899947302246
- Basic UDI-DI
- 789994730026R
- EMDN Code
- Y063018 External breast prostheses
- Device Class
- Class I
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- BR-MF-000055005
- Authorised representative
- Rápido e Contínuo Unipessoal LDA PT-AR-000039288
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No