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49 device results listed.

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DBB-EXA

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: NIKKISO CO., LTD.
Manufacturer SRN: JP-MF-000019276
UDI-DI: 04987671600004
Basic UDI-DI: 4987671HD-EqA2P
Reference: DBB-EXA
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Germany
Authorised representative: NIKKISO Medical Europe GmbH
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

04571312780103

Single Patient Dialysis Machine DIAMAX WOW

Class IIbMDR 2017/745Not intended for EU marketActive deviceCMR substanceDirect markingMeasuring function

Manufacturer: YAC ELEX Co.,LTD.
Manufacturer SRN: JP-MF-000046430
UDI-DI: 04571312780103
Basic UDI-DI: 457131278DIAMAXWOWAZ
Reference: DIAMAX WOW 110V
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

04571312780097

Single Patient Dialysis Machine DIAMAX WOW

Class IIbMDR 2017/745Not intended for EU marketActive deviceCMR substanceDirect markingMeasuring function

Manufacturer: YAC ELEX Co.,LTD.
Manufacturer SRN: JP-MF-000046430
UDI-DI: 04571312780097
Basic UDI-DI: 457131278DIAMAXWOWAZ
Reference: DIAMAX WOW 230V
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:06

Manufacturer products Authorised representative products Authorised representative actors View details

ADVOS Hämodialysesystem

Version B

Class IIbMDR 2017/745On the market

Manufacturer: ADVITOS GmbH
Manufacturer SRN: DE-PR-000038149
UDI-DI: 04251395500385
Basic UDI-DI: 4251395500068U
Reference: 1007400
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:01

Manufacturer products View details

ADVOS procedure pack

Version A

Class IIbMDR 2017/745On the market

Manufacturer: ADVITOS GmbH
Manufacturer SRN: DE-PR-000038149
UDI-DI: 04251395500200
Basic UDI-DI: 4251395500078W
Reference: 1004207
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:01

Manufacturer products View details

OMNI®

OMNI

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: B. Braun Avitum AG
Manufacturer SRN: DE-MF-000005127
UDI-DI: 04046955734344
Basic UDI-DI: 40392390000016182P
Reference: 7107515
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 22:43

Manufacturer products View details

OMNI®

OMNI

Class IIbMDR 2017/745On the marketActive device

Manufacturer: B. Braun Avitum AG
Manufacturer SRN: DE-MF-000005127
UDI-DI: 04046955904785
Basic UDI-DI: 40392390000016182P
Reference: 7107517
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 09:33

Manufacturer products View details

OMNI®

Class IIbNot specifiedOn the marketActive device

Manufacturer: B. Braun Avitum AG
Manufacturer SRN: DE-MF-000005127
UDI-DI: 04046955904792
Basic UDI-DI: 40392390000016182P
Reference: 7107516
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:12

Manufacturer products View details

Renalyx Extending Renal Care

RxT21

Class IIbMDDNo longer on the marketActive deviceAdministering medicineReprocessed

Manufacturer: Renalyx Health Systems Pvt Ltd
Manufacturer SRN: IN-MF-000031529
UDI-DI: D-IN-MF-00003152921GG
Basic UDI-DI: B-IN-MF-00003152921GG
Reference: RxT21 UM-001
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Renalyx Extending Renal Care

RxT17

Class IIbMDDNo longer on the marketActive deviceAdministering medicineReprocessed

Manufacturer: Renalyx Health Systems Pvt Ltd
Manufacturer SRN: IN-MF-000031529
UDI-DI: D-IN-MF-00003152917GR
Basic UDI-DI: B-IN-MF-00003152917GR
Reference: RxT17 UM-001
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Hemodialysis Equipments

SWS-4000, SWS-4000A, SWS-5000, SWS-5000A, SWS-5000B, SWS-6000, SWS-6000A

Class IIbMDDOn the marketActive device

Manufacturer: SWS Hemodialysis Care Co.,Ltd.
Manufacturer SRN: CN-MF-000024516
UDI-DI: D-CNMF00002451669557484HC
Basic UDI-DI: B-CNMF00002451669557484HC
Reference: SWS-4000, SWS-4000A, SWS-5000, SWS-5000A, SWS-5000B, SWS-6000, SWS-6000A
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:06

Manufacturer products Authorised representative products Authorised representative actors View details

S³ Haemodialysis Machine

CC39

Class IIbMDDOn the marketActive device

Manufacturer: Physidia S.A.S.
Manufacturer SRN: FR-MF-000011761
UDI-DI: 03770023297028
Basic UDI-DI: B-03770023297028
Reference: CC39
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:28

Manufacturer products View details

04571312780110

Class IIbNot specifiedNot intended for EU marketCMR substanceDirect marking

Manufacturer: YAC ELEX Co.,LTD.
Manufacturer SRN: JP-MF-000046430
UDI-DI: 04571312780110
Basic UDI-DI: 457131278DIAMAXWOWAZ
Reference: DIAMAX WOW 230V Brazil
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 05.07.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

04571312780127

Class IIbNot specifiedNot intended for EU marketCMR substanceDirect marking

Manufacturer: YAC ELEX Co.,LTD.
Manufacturer SRN: JP-MF-000046430
UDI-DI: 04571312780127
Basic UDI-DI: 457131278DIAMAXWOWAZ
Reference: DIAMAX WOW 110V Brazil
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 05.07.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

AK 98

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Vantive Health GmbH
Manufacturer SRN: CH-MF-000038981
UDI-DI: 07332414201593
Basic UDI-DI: 7332414VA0000012H
Reference: 956013
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Spain
Authorised representative: Vantive S.r.l.
Last updated: 03.07.2026 04:08

Manufacturer products Authorised representative products Authorised representative actors View details

Hemodialysis Equipment

Aide1, Aide1 SE, Aide1 Pro, Aide1 Max, Aide2, Aide2 Pro, Aide3, Aide3 Pro

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GUANGZHOU OCI MEDICAL DEVICES CO., LTD.
Manufacturer SRN: CN-MF-000036303
UDI-DI: 06976533600014
Basic UDI-DI: 69765336000001ZS
Reference: S01020200001
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 21:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dora

DORA-6000

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Guangzhou Phoenix Medical Equipment Co., LTD.
Manufacturer SRN: CN-MF-000012210
UDI-DI: 06974325110017
Basic UDI-DI: 69743251108784Y2
Reference: DORA-6000
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Germany
Authorised representative: MedNet EC-REP C IIb GmbH
Last updated: 02.07.2026 15:54

Manufacturer products Authorised representative products Authorised representative actors View details

Haemodialysis equipment

D800Plus, D800H, D800S, D50

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Guangdong Biolight Meditech Co., Ltd
Manufacturer SRN: CN-MF-000006333
UDI-DI: 06932562300479
Basic UDI-DI: 693256232000144
Reference: D50
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Dialog iQ®

Dialog iQ

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: B. Braun Avitum AG
Manufacturer SRN: DE-MF-000005127
UDI-DI: 04046955815159
Basic UDI-DI: 40392390000005292G
Reference: 7104014
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 17:28

Manufacturer products View details

Hemodialysis Equipment

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: SWS Hemodialysis Care Co.,Ltd.
Manufacturer SRN: CN-MF-000024516
UDI-DI: 06955748410618
Basic UDI-DI: 69557484SWS-6000EE
Reference: SWS-6000A
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 28.06.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details