Tubing Sets for Hemodialysis

by Bain Medical Equipment(Guangzhou)Co., Ltd.

Ref BAIN-BL-061G, BAIN-BL-067E, BAIN-BL-030E, BAIN-BL-161, BAIN-BL-049E, BAIN-BL-022E, BAIN-BL-090, BAIN-A.V.F-070DE, BAIN-A.V.F-084VE, BAIN-BL-075E, BAIN-A.V.F-026SE, BAIN-BL-106E, BAIN-BL-007, BAIN-BL-046G, BAIN-BL-070, BAIN-BL-223, BAIN-HB-002, BAIN-BL-235, BAIN-BL-086, BAIN-BL-111, BAIN-BL-105, BAIN-BL-004, BAIN-BL-032, BAIN-BL-022, BAIN-BL-034, BAIN-BL-259, BAIN-BL-092G, B-24HF, BAIN-A.V.F-010E, BAIN-A.V.F-048T, BAIN-BL-019G, BAIN-BL-149, BAIN-A.V.F-088VE, BAIN-BL-282, BAIN-BL-025, BAIN-A.V.F-070E, BAIN-BL-017, BAIN-BL-073E, BAIN-BL-228, BAIN-BL-244, BAIN-BL-088G, BAIN-BL-042, BAIN-BL-001, BAIN-BL-225, BAIN-BL-114G, BAIN-BL-008G, BAIN-BL-076E, BAIN-A.V.F-038TE, BAIN-BL-014, BAIN-HDF-02, BAIN-BL-062EModel BAIN-BL-001G, BAIN-BL-002G,...BAIN-BL-118G, BAIN-BL-002E,BAIN-BL-006E,BAIN-BL-009E,BAIN-BL-010E,BAIN-BL-014E,BAIN-BL-034E,BAIN-BL-036E,BAIN-BL-037E,BAIN-BL-038E,BAIN-BL-053E,BAIN-BL-059E,BAIN-BL-064E,BAIN-BL-069E,BAIN-BL-070E,BAIN-BL-075E,BAIN-BL-084E,BAIN-BL-108E,BAIN-BL-109E,BAIN-BL-110E, 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, 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, AVF-BR2515BE-15, AVF-BR2515BE-16, AVF-BR2515E-15, AVF-BR2515E-16, BAIN-A.V.F-002SE, BAIN-A.V.F-006SE, BAIN-A.V.F-010SE, BAIN-A.V.F-026SE, BAIN-A.V.F-034SE, BAIN-A.V.F-050SE, BAIN-A.V.F-066SE, BAIN-A.V.F-070SE, BAIN-A.V.F-074SE, BAIN-A.V.F-086SE, BAIN-A.V.F-090SE, B-13HF~B-24HF, BAIN-A.V.F-002, BAIN-A.V.F-006, BAIN-A.V.F-038T, BAIN-A.V.F-042T, BAIN-A.V.F-046T, BAIN-A.V.F-048T, BAIN-HDF-02，BAIN-HDF-04，BAIN-HDF-07，BAIN-HDF-08

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163025↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	Number6948082701183AA Basic UDI-DI	Date4 Apr 2026Registered	StatusActive
European Union	CE/MDR EUDAMED	Number6948082701183AA Basic UDI-DI	Date4 Apr 2026Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK163025	Date20 Jul 2017Issued	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD, CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Trade Name: Tubing Sets for Hemodialysis
Disposable A.V. Fistula Needle Sets(Dull needle series)
Disposable A.V. Fistula Needle Sets
DORA Tubing Sets for Hemodialysis
Disposable A.V. Fistula Needle Sets(Safety needle series)
DORA Hemodialysis Bicarbonate
DORA Hollow Fiber Dialyzer
DORA Disposable A.V.Fistula Needle Sets
DORA Disposable A.V. Fistula Needle Sets
DORA Fluid supplementary tubing sets for blood purification
Device Name: Hemodialysis Bicarbonate
Hollow Fiber Dialyzer
Fluid supplementary tubing sets for blood purification
Model / Reference: BAIN-BL-001G, BAIN-BL-002G, ...BAIN-BL-118G, BAIN-BL-061G, BAIN-BL-002E, BAIN-BL-006E, BAIN-BL-009E, BAIN-BL-010E, BAIN-BL-014E, BAIN-BL-034E, BAIN-BL-036E, BAIN-BL-037E, BAIN-BL-038E, BAIN-BL-053E, BAIN-BL-059E, BAIN-BL-064E, BAIN-BL-069E, BAIN-BL-070E, BAIN-BL-075E, BAIN-BL-084E, BAIN-BL-108E, BAIN-BL-109E, BAIN-BL-110E, BAIN-BL-067E, BAIN-BL-030E, 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, BAIN-BL-161, BAIN-BL-049E, BAIN-BL-022E, BAIN-BL-090, 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, AVF-BR2515BE-15, AVF-BR2515BE-16, AVF-BR2515E-15, AVF-BR2515E-16, BAIN-A.V.F-084VE, BAIN-A.V.F-002SE, BAIN-A.V.F-006SE, BAIN-A.V.F-010SE, BAIN-A.V.F-026SE, BAIN-A.V.F-034SE, BAIN-A.V.F-050SE, BAIN-A.V.F-066SE, BAIN-A.V.F-070SE, BAIN-A.V.F-074SE, BAIN-A.V.F-086SE, BAIN-A.V.F-090SE, BAIN-BL-106E, BAIN-BL-007, BAIN-BL-046G, BAIN-BL-070, BAIN-BL-223, BAIN-HB-002, BAIN-BL-235, BAIN-BL-086, BAIN-BL-111, BAIN-BL-105, BAIN-BL-004, BAIN-BL-032, BAIN-BL-022, BAIN-BL-259, BAIN-BL-092G, B-13HF~B-24HF, B-24HF, BAIN-A.V.F-010E, BAIN-A.V.F-002, BAIN-A.V.F-006, BAIN-A.V.F-038T, BAIN-A.V.F-042T, BAIN-A.V.F-046T, BAIN-A.V.F-048T, BAIN-BL-019G, BAIN-BL-149, BAIN-A.V.F-088VE, BAIN-BL-282, BAIN-BL-025, BAIN-A.V.F-070E, BAIN-BL-017, BAIN-BL-073E, BAIN-BL-228, BAIN-BL-244, BAIN-BL-088G, BAIN-BL-042, BAIN-BL-225, BAIN-BL-114G, BAIN-BL-008G, BAIN-BL-076E, BAIN-A.V.F-038TE, BAIN-BL-014, BAIN-HDF-02，BAIN-HDF-04，BAIN-HDF-07，BAIN-HDF-08, BAIN-HDF-02, BAIN-BL-062E

Primary DI / UDI-DI: 06948082708206, 06948082704222, 06948082700743, 06948082706240, 06948082704048, 06948082700224, 06948082705533, 06948082751059, 06948082774348, 06948082704291, 06948082770098, 06948082704604, 06948082701245, 06948082708053, 06948082705335, 06948082706868, 06948082751011, 06948082706981, 06948082705496, 06948082705748, 06948082705687, 06948082701214, 06948082704956, 06948082704857, 06948082704970, 06948082707223, 06948082708510, 06948082701924, 06948082709395, 06948082720055, 06948082707780, 06948082706127, 06948082773136, 06948082707452, 06948082704888, 06948082709425, 06948082704802, 06948082701900, 06948082706912, 06948082707070, 06948082708473, 06948082705052, 06948082700972, 06948082706882, 06948082708732, 06948082707674, 06948082704307, 06948082751103, 06948082704772, 06948082751585, 06948082704178
Basic UDI-DI: 6948082701183AA, 6948082701182A8, 6948082701181A6, 6948082702142A3, 69480827021329Y, 6948082702152A6, 6948082711774BJ, 6948082703422AK, 69480827021319W, 6948082710181AA
EMDN Code: F020102, A010401, F040201, F01060303, F020199

Device Class: Class IIa
Class IIb
EU market of registration: Germany
Sweden
Greece
Bulgaria
Romania
Czechia

Manufacturer details

EUDAMED SRN: CN-MF-000005196
Authorised representative: Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Bain Medical Equipment(Guangzhou)Co., Ltd.

bain Hollow Fiber Dialyzer

Class IIb
DORA Disposable A.V.Fistula Needle Sets

Class IIa
DORA Hollow Fiber Dialyzer

Class IIb
Tubing Sets for Hemodialysis

Class IIa
DORA Disposable A.V. Fistula Needle Sets

Class IIa
bain Tubing sets for hemodialysis

Class IIa

See all devices from Bain Medical Equipment(Guangzhou)Co., Ltd. →

Properties

Sterile YesEUDAMEDNoEUDAMED
CMR Substance YesEUDAMEDNoEUDAMED

Other properties (11)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No