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Disposable A.V. Fistula Needle Sets(Safety needle series)
EUDAMEDClass IIa (EU MDR)
Ref BAIN-A.V.F-010SEModel BAIN-A.V.F-002SE, BAIN-A.V.F-006SE, BAIN-A.V.F-010SE, BAIN-A.V.F-026SE, BAIN-A.V.F-034SE, BAIN-A.V.F-050SE, BAIN-A.V.F-066SE, BAIN-A.V.F-070SE, BAIN-A.V.F-074SE, BAIN-A.V.F-086SE, BAIN-A.V.F-090SE
Identity
- Trade Name
- Disposable A.V. Fistula Needle Sets(Safety needle series) EUDAMEDDORA EUDAMED
- Device Name
- Disposable A.V. Fistula Needle Sets(Safety needle series) EUDAMEDDisposable A.V. Fistula Needle Sets (Safety Needle series) EUDAMED
- Model / Reference
- BAIN-A.V.F-002SE, BAIN-A.V.F-006SE, BAIN-A.V.F-010SE, BAIN-A.V.F-026SE, BAIN-A.V.F-034SE, BAIN-A.V.F-050SE, BAIN-A.V.F-066SE, BAIN-A.V.F-070SE, BAIN-A.V.F-074SE, BAIN-A.V.F-086SE, BAIN-A.V.F-090SE EUDAMEDBAIN-A.V.F-010SE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948082709470 EUDAMED
- Basic UDI-DI
- 6948082702152A6 EUDAMEDB-06948082709470 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Disposable A.V. Fistula Needle Sets(Safety needle series) by Bain Medical Equipment(Guangzhou)Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6948082702152A6 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6948082702152A6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bain Medical Equipment(Guangzhou)Co., Ltd.
- EUDAMED SRN
- CN-MF-000005196
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 5476a188-56ba-4025-b4fb-6765fc632502 61 fields · synced Oct 6, 2026
- EUDAMED fa084b30-425f-4199-87ef-e6b607b59df9 61 fields · synced Oct 6, 2026