DORA Disposable A.V.Fistula Needle Sets(Safety Needle series)
by Bain Medical Equipment(Guangzhou)Co., Ltd. China EUDAMED
Ref BAIN-A.V.F-082VSEModel BAIN-A.V.F-001SE ~BAIN-A.V.F-112SE, BAIN-A.V.F-001ASE ~BAIN-A.V.F-100ASE, BAIN-A.V.F-001VSE ~BAIN-A.V.F-100VSE, BAIN-A.V.F-001STE ~BAIN-A.V.F-100STE
EMDN A010401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6948082702152A6 | Date27 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable A.V. Fistula Needle Sets (Safety Needle series)
- Model / Reference
- BAIN-A.V.F-001SE ~BAIN-A.V.F-112SE, BAIN-A.V.F-001ASE ~BAIN-A.V.F-100ASE, BAIN-A.V.F-001VSE ~BAIN-A.V.F-100VSE, BAIN-A.V.F-001STE ~BAIN-A.V.F-100STE, BAIN-A.V.F-082VSE
- Primary DI / UDI-DI
- 06948082775246
- Basic UDI-DI
- 6948082702152A6
- 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
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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 06948082775246|6948082702152A6