DORA Disposable A.V.Fistula Needle Sets
by Bain Medical Equipment(Guangzhou)Co., Ltd. China EUDAMED
Ref BAIN-A.V.F-086VEModel AVF-BR2515BE-15, AVF-BR2515BE-16, AVF-BR2515E-15, AVF-BR2515E-16
EMDN A010401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69480827021329Y | Date26 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable A.V. Fistula Needle Sets
- Model / Reference
- AVF-BR2515BE-15, AVF-BR2515BE-16, AVF-BR2515E-15, AVF-BR2515E-16, BAIN-A.V.F-086VE
- Primary DI / UDI-DI
- 06948082774430
- Basic UDI-DI
- 69480827021329Y
- EMDN Code
- A010401 Arteriovenous fistula needles
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000005196
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 054deb62-fe56-411d-8229-cd41c7a5acdd