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Fistula Catheter
EUDAMEDClass IIa (EU MDR)
Ref BAIN-FC-002SModel BAIN-FC-001, BAIN-FC-001S, BAIN-FC-002, BAIN-FC-002S, BAIN-FC-003, BAIN-FC-003S, BAIN-FC-004, BAIN-FC-004S, BAIN-FC-005, BAIN-FC-005S, BAIN-FC-006, BAIN-FC-006SRef BAIN-FC-006SRef BAIN-FC-003SRef BAIN-FC-001Ref BAIN-FC-004Ref BAIN-FC-005SRef BAIN-FC-002
Identity
- Trade Name
- Fistula Catheter EUDAMED
- Device Name
- Fistula Catheter EUDAMED
- Model / Reference
- BAIN-FC-001, BAIN-FC-001S, BAIN-FC-002, BAIN-FC-002S, BAIN-FC-003, BAIN-FC-003S, BAIN-FC-004, BAIN-FC-004S, BAIN-FC-005, BAIN-FC-005S, BAIN-FC-006, BAIN-FC-006S EUDAMEDBAIN-FC-002S EUDAMEDBAIN-FC-006S EUDAMEDBAIN-FC-003S EUDAMEDBAIN-FC-001 EUDAMEDBAIN-FC-004 EUDAMEDBAIN-FC-005S EUDAMEDBAIN-FC-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948082752001 EUDAMED06948082752049 EUDAMED06948082752018 EUDAMED06948082751936 EUDAMED06948082751967 EUDAMED06948082752032 EUDAMED06948082751943 EUDAMED
- Basic UDI-DI
- 6948082720282AU 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
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
Fistula Catheter by Bain Medical Equipment(Guangzhou)Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6948082720282AU | 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 (7)
- EUDAMED c852a80c-6509-4ba1-81f4-7360d2b583f9 61 fields · synced Oct 6, 2026
- EUDAMED b8d14a38-0afe-47fb-8f8b-f347f9f2e086 61 fields · synced May 17, 2026
- EUDAMED 8b5db958-ed3c-4718-b2b2-8f10a25b6b48 61 fields · synced May 17, 2026
- EUDAMED 7fa00d22-b867-4d4b-84ca-77cb9d98f7eb 61 fields · synced May 17, 2026
- EUDAMED 0e555ed0-0b12-4bbf-a071-d165697d2823 61 fields · synced May 18, 2026
- EUDAMED e6ee8d21-1c23-443a-813d-ba7bae401151 61 fields · synced May 18, 2026
- EUDAMED 54df298c-6d2d-46bc-9cb2-726ce1129868 61 fields · synced May 19, 2026