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Tubing Sets for Hemodialysis
EUDAMEDClass IIa (EU MDR)
Ref BAIN-BL-113Model BAIN-BL-001, BAIN-BL-029, BAIN-BL-034, BAIN-BL-088, BAIN-BL-130, BAIN-BL-132, BAIN-BL-141, BAIN-BL-173, BAIN-BL-252
Identity
- Trade Name
- Tubing Sets for Hemodialysis EUDAMED
- Device Name
- Tubing Sets for Hemodialysis EUDAMED
- Model / Reference
- BAIN-BL-001, BAIN-BL-029, BAIN-BL-034, BAIN-BL-088, BAIN-BL-130, BAIN-BL-132, BAIN-BL-141, BAIN-BL-173, BAIN-BL-252 EUDAMEDBAIN-BL-113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948082705762 EUDAMED
- Basic UDI-DI
- 6948082701181A6 EUDAMED
- EMDN Code
- F020102 ARTERIOVENOUS DIALYSIS LINES, TWO 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
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
Tubing Sets for Hemodialysis 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 | 6948082701181A6 | 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 e752f3dc-5597-4ed2-b8f9-28cf0e43fc5a 61 fields · synced Oct 7, 2026