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RenalGuard Console

FM1

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring function

Manufacturer: CardioRenal Systems, Inc.
Manufacturer SRN: US-MF-000035063
UDI-DI: 00866379000122
Basic UDI-DI: B-00866379000122
Reference: FM1
EMDN: A03010105
EMDN description: INFUSION PUMP CONTROLLERS
First on market country: Germany
Authorised representative: RenalGuard Solutions EU GmbH
Last updated: 05.07.2026 11:49

Manufacturer products Authorised representative products Authorised representative actors View details

00827002169180

Ureteroscopy Irrigation System

Class IMDDOn the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002169180
Basic UDI-DI: B-00827002169180
Reference: 050350
EMDN: A03010202
EMDN description: UROLOGICAL IRRIGATION CONTROLLERS
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 04.07.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Tubing set, disposable, 4m

Tubing Set, disposable

Class IIaMDDOn the marketAdministering medicineSingle useSterile

Manufacturer: NOUVAG AG
Manufacturer SRN: CH-MF-000018882
UDI-DI: +ENOU60229M
Basic UDI-DI: B-+ENOU60229M
Reference: 6022
EMDN: A03010103
EMDN description: INFUSION CONTROLLERS WITH FLOW REGULATOR
First on market country: Germany
Authorised representative: Nouvag Dental- und Medizintechnik GmbH
Last updated: 04.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

MEDRAD® Salient Contrast Injection System MEDRAD® Vistron Plus Contrast Injection System MEDRAD® Salient MEDRAD® Vistron Plus Heat Maintainer

Class IMDR 2017/745On the market

Manufacturer: IMAXEON PTY LTD
Manufacturer SRN: AU-MF-000009702
UDI-DI: 09345390002779
Basic UDI-DI: 934539000TFCN-0102IC5
Reference: DC022
EMDN: A030105
EMDN description: FLUIDS HEATING SYSTEMS
First on market country: Netherlands
Authorised representative: Bayer Medical Care B.V.
Last updated: 04.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Nubeno

Blood Transfusion Set (B.T. Set)

Class IIaMDR 2017/745Not intended for EU marketAdministering medicineSingle useSterile

Manufacturer: Nubeno Healthcare Private Limited
Manufacturer SRN: IN-MF-000014550
UDI-DI: 89080170183724
Basic UDI-DI: 8908017018BTS015J
Reference: NB-01
EMDN: A03010102
EMDN description: INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS)
First on market country: -
Authorised representative: EUCEREP B.V.
Last updated: 03.07.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

RMS VENTED INFUSION SET

INFUSION SET

Class IIaMDR 2017/745On the marketAdministering medicineMeasuring functionSingle useSterile

Manufacturer: Romsons Group Private Limited
Manufacturer SRN: IN-MF-000036506
UDI-DI: 08907265011005
Basic UDI-DI: 8907265C014YS
Reference: SS 3060 KAD
EMDN: A03010103
EMDN description: INFUSION CONTROLLERS WITH FLOW REGULATOR
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

Maisflow™

Flow Regulator

Class IMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Mais India Medical Devices Pvt. Ltd.
Manufacturer SRN: IN-MF-000021842
UDI-DI: 08906065482084
Basic UDI-DI: 890606548I09MA
Reference: MI/CA/01-000-E
EMDN: A030104
EMDN description: FLOW REGULATORS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

Intravenous infusion set / I.V.Set / IV Set / IV Giving set / Infusion Set vented drip chamber

Intravenous infusion set / I.V.Set / IV Set / IV Giving set / Infusion Set

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Harsoria Healthcare Pvt. Ltd.
Manufacturer SRN: IN-MF-000018349
UDI-DI: 08904399105785
Basic UDI-DI: 89043991HSETP0447
Reference: 0578
EMDN: A03010101
EMDN description: INFUSION CONTROLLERS WITH OR W/O AIR INLET
First on market country: Ireland
Authorised representative: mdi Europa GmbH
Last updated: 03.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Flow Regulator

Flow Regulator / IV Flow Regulator / Flow Regulator Extension Set

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Harsoria Healthcare Pvt. Ltd.
Manufacturer SRN: IN-MF-000018349
UDI-DI: 08904399104238
Basic UDI-DI: 89043991HSETP0345
Reference: 0423
EMDN: A030104
EMDN description: FLOW REGULATORS
First on market country: Poland
Authorised representative: mdi Europa GmbH
Last updated: 03.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Gloreg

I.V. flow regulator extension set

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Global Medikit Limited
Manufacturer SRN: IN-MF-000013635
UDI-DI: 08903545001261
Basic UDI-DI: 8903545GMLIVF024LC
Reference: 4660012G
EMDN: A030104
EMDN description: FLOW REGULATORS
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:27

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SURUFLOW

3024

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: SURU INTERNATIONAL PVT LTD
Manufacturer SRN: IN-MF-000023736
UDI-DI: 08902141113675
Basic UDI-DI: 89021413024PW
Reference: 3024
EMDN: A030104
EMDN description: FLOW REGULATORS
First on market country: Malta
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

SURUVOL

2030

Class IIaMDR 2017/745On the marketAdministering medicineMeasuring functionSingle useSterile

Manufacturer: SURU INTERNATIONAL PVT LTD
Manufacturer SRN: IN-MF-000023736
UDI-DI: 08902141102471
Basic UDI-DI: 89021412030PJ
Reference: 2030.100
EMDN: A03010102
EMDN description: INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS)
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

MEASURED VOLUME IV SET WITH NEEDLE

Infusion Set with / without Needle

Class IIaMDR 2017/745On the marketAdministering medicineMeasuring functionSingle useSterile

Manufacturer: Romsons International (Unit II)
Manufacturer SRN: IN-MF-000024594
UDI-DI: 08902120305718
Basic UDI-DI: 8902120C014RX
Reference: GS-3057
EMDN: A03010103
EMDN description: INFUSION CONTROLLERS WITH FLOW REGULATOR
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

Transfusion Sets (BT Set)

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Poly Medicure Limited
Manufacturer SRN: IN-MF-000043009
UDI-DI: 08902095700914
Basic UDI-DI: 890209570091FV
Reference: 70091
EMDN: A03010102
EMDN description: INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS)
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

Transfusion Sets (BT Set)

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Poly Medicure Limited
Manufacturer SRN: IN-MF-000042557
UDI-DI: 08902095700907
Basic UDI-DI: 890209570092FX
Reference: 70090
EMDN: A03010102
EMDN description: INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS)
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

00890404570007

BLOOD TRANSFUSION SET

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Vitromed Healthcare
Manufacturer SRN: IN-MF-000021420
UDI-DI: 00890404570007
Basic UDI-DI: 89040457000SD
Reference: 7000
EMDN: A03010102
EMDN description: INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS)
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

00890404520019

INFUSION SET WITH AND WITHOUT VENT

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Vitromed Healthcare
Manufacturer SRN: IN-MF-000021420
UDI-DI: 00890404520019
Basic UDI-DI: 89040452001RC
Reference: 2001
EMDN: A03010103
EMDN description: INFUSION CONTROLLERS WITH FLOW REGULATOR
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

Burette Infusion Sets

Burette Infusion sets

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Poly Medicure Limited
Manufacturer SRN: IN-MF-000043009
UDI-DI: 08902095145043
Basic UDI-DI: 890209514501EM
Reference: 14504
EMDN: A03010104
EMDN description: INFUSION MICRO-CONTROLLERS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Burette Infusion Sets

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Poly medicure limited
Manufacturer SRN: IN-MF-000043010
UDI-DI: 08902095145005
Basic UDI-DI: 890209514500EK
Reference: 14500
EMDN: A03010104
EMDN description: INFUSION MICRO-CONTROLLERS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Infusion Sets with/ without airvent

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Poly Medicure Limited
Manufacturer SRN: IN-MF-000042557
UDI-DI: 08902095141908
Basic UDI-DI: 890209514005E4
Reference: 14190
EMDN: A03010101
EMDN description: INFUSION CONTROLLERS WITH OR W/O AIR INLET
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details