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Disposable A.V. Fistula Needle Sets
EUDAMEDClass IIa (EU MDR)
Ref AVF-BR2515E-15Model AVF-BR2515BE-15, AVF-BR2515BE-16, AVF-BR2515E-15, AVF-BR2515E-16
Identity
- Trade Name
- Disposable A.V. Fistula Needle Sets EUDAMEDAsahi KASEI EUDAMED
- Device Name
- Disposable A.V. Fistula Needle Sets EUDAMED
- Model / Reference
- AVF-BR2515BE-15, AVF-BR2515BE-16, AVF-BR2515E-15, AVF-BR2515E-16 EUDAMEDAVF-BR2515E-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948082771293 EUDAMED
- Basic UDI-DI
- 69480827021329Y EUDAMEDB-06948082771293 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMEDEUDAMED
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 by Bain Medical Equipment (Guangzhou) Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69480827021329Y | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69480827021329Y | 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 53ac2afa-f64c-4b44-a933-be294542ca42 61 fields · synced Oct 7, 2026
- EUDAMED faf908a1-e71a-45c8-95f1-6514d22edfa7 61 fields · synced Jun 18, 2026