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Fistula Catheter
EUDAMEDClass IIa (EU MDR)
Ref BAIN-FC-003Model 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
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-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948082751950 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 (1)
- EUDAMED 1a0a6874-e19a-4066-b5e6-3d74abdfa54e 61 fields · synced Oct 6, 2026