← Back to catalogue
Disposable A.V. Fistula Needle Sets(Dull needle series)
EUDAMEDClass IIa (EU MDR)
Ref BAIN-A.V.F-034DEModel BAIN-A.V.F-010DE, BAIN-A.V.F-012DE, BAIN-A.V.F-034DE, BAIN-A.V.F-036DE, BAIN-A.V.F-050DE, BAIN-A.V.F-070DE, BAIN-A.V.F-074DE, BAIN-A.V.F-078DE, BAIN-A.V.F-086DE, BAIN-A.V.F-090DE, BAIN-A.V.F-094DERef BAIN-A.V.F-012DE
Identity
- Trade Name
- Disposable A.V. Fistula Needle Sets(Dull needle series) EUDAMEDDORA EUDAMED
- Device Name
- Disposable A.V. Fistula Needle Sets(Dull needle series) EUDAMED
- Model / Reference
- BAIN-A.V.F-010DE, BAIN-A.V.F-012DE, BAIN-A.V.F-034DE, BAIN-A.V.F-036DE, BAIN-A.V.F-050DE, BAIN-A.V.F-070DE, BAIN-A.V.F-074DE, BAIN-A.V.F-078DE, BAIN-A.V.F-086DE, BAIN-A.V.F-090DE, BAIN-A.V.F-094DE EUDAMEDBAIN-A.V.F-034DE EUDAMEDBAIN-A.V.F-012DE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948082770142 EUDAMED06948082771514 EUDAMED
- Basic UDI-DI
- 6948082702142A3 EUDAMEDB-06948082770142 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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(Dull 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 | 6948082702142A3 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6948082702142A3 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bain Medical Equipment(Guangzhou)Co., Ltd.
- EUDAMED SRN
- CN-MF-000005196
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED 38b48c1b-87af-4181-a0a7-ae009e9aba61 61 fields · synced Oct 8, 2026
- EUDAMED 4cf954a0-a1ea-483a-a696-fd67f025cb33 61 fields · synced May 17, 2026
- EUDAMED 096ede2b-9f30-4323-a795-9367cadf6f50 61 fields · synced Oct 8, 2026