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Infusion Sets for Single Use (B1-1Y2DLPN)

Class IIbMDR 2017/745On the marketAdministering medicineContains latexSingle useSterile

Manufacturer: Jiangxi Hongda Medical Equipment Group Ltd.
Manufacturer SRN: CN-MF-000006019
UDI-DI: 06920756725009
Basic UDI-DI: 69207567GSYQ000199
Reference: B101L
EMDN: A03010103
EMDN description: INFUSION CONTROLLERS WITH FLOW REGULATOR
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

evercare inLine® UROLOGICAL SET, Y-TYPE, PVC Free, 215 cm

Urology Sets

Class IIaMDR 2017/745No longer on the marketAdministering medicineSingle useSterile

Manufacturer: OneMed Group Oy
Manufacturer SRN: FI-MF-000000642
UDI-DI: 06438129117516
Basic UDI-DI: 6438129B0028HG
Reference: 10555
EMDN: A03010202
EMDN description: UROLOGICAL IRRIGATION CONTROLLERS
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 17:54

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EpiHeart Catheter for supernatant removal

Catheter for supernatant removal

Class IMDR 2017/745On the marketSingle use

Manufacturer: EpiHeart Oy
Manufacturer SRN: FI-MF-000018287
UDI-DI: 06429810632142
Basic UDI-DI: 6429810632CATSUP01ZM
Reference: 60-000-002
EMDN: A0399
EMDN description: TUBULAR DEVICES - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:40

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EpiHeart Adapter for Centrifuge

Adapter for Centrifuge

Class IMDR 2017/745On the marketSingle use

Manufacturer: EpiHeart Oy
Manufacturer SRN: FI-MF-000018287
UDI-DI: 06429810632128
Basic UDI-DI: 6429810632ADACEN01GZ
Reference: 66-000-002
EMDN: A0399
EMDN description: TUBULAR DEVICES - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:40

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Ultramed Burette Set measured volume fluid administration set - 150 ml

Ultramed Burette Set measured volume fluid administration set

Class IIaMDR 2017/745On the marketAdministering medicineContains latexDirect markingMeasuring functionSingle useSterile

Manufacturer: Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)
Manufacturer SRN: EG-MF-000038562
UDI-DI: 06223004250897
Basic UDI-DI: 622300425BUS1016UU
Reference: 1016-150
EMDN: A03010104
EMDN description: INFUSION MICRO-CONTROLLERS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 17:30

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ULTRAMED EXTENSION TUBE Low Pressure Without 3 Way Stop Cock - 7 cm

ULTRAMED EXTENSION TUBE

Class IMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)
Manufacturer SRN: EG-MF-000038562
UDI-DI: 06223004250231
Basic UDI-DI: 622300425EXT1011XP
Reference: 1011/LP-07
EMDN: A03020101
EMDN description: LOW PRESSURE EXTENSION LINES
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 17:30

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ULTRAMED I.V. INFUSION SET With Non-vented Spike

I.V. INFUSION SET

Class IIaMDR 2017/745On the marketAdministering medicineContains latexSingle useSterile

Manufacturer: Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)
Manufacturer SRN: EG-MF-000038562
UDI-DI: 06223004250125
Basic UDI-DI: 622300425IVS1009Z3
Reference: 1009
EMDN: A03010101
EMDN description: INFUSION CONTROLLERS WITH OR W/O AIR INLET
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 17:30

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Tubing Systems and Accessories for Fluid Delivery

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: Sky Medical a.s.
Manufacturer SRN: SK-MF-000001475
UDI-DI: 18586021470378
Basic UDI-DI: 602147CLSET5L
Reference: CL-H15002
EMDN: A03020102
EMDN description: HIGH PRESSURE EXTENSION LINES
First on market country: Slovakia
Authorised representative: -
Last updated: 31.07.2026 16:52

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Tubing Systems and Accessories for Fluid Delivery

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: Sky Medical a.s.
Manufacturer SRN: SK-MF-000001475
UDI-DI: 18586021470361
Basic UDI-DI: 602147CMSET5T
Reference: CM-ML0002
EMDN: A03020102
EMDN description: HIGH PRESSURE EXTENSION LINES
First on market country: Slovakia
Authorised representative: -
Last updated: 31.07.2026 16:52

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PROLONGATEURS

ongueurs et diametres différents type de extrémités: Luer Lock Male ou Femelle

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

Manufacturer: Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd
Manufacturer SRN: TN-MF-000023623
UDI-DI: 06192493100993
Basic UDI-DI: 61924931RALLONGE76
Reference: R1150D1S2C1C
EMDN: A03020199
EMDN description: EXTENSIONS - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 16:51

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Perfuseur avec régulateur de débit de précision

Chambre de goutement : de volume variable; Embout: de forme variable

Class IIaMDR 2017/745On the marketAdministering medicineMeasuring functionSingle useSterile

Manufacturer: Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd
Manufacturer SRN: TN-MF-000023623
UDI-DI: 06192493100979
Basic UDI-DI: 61924931INFMICROCONTROLSE
Reference: PS2a23HLLC
EMDN: A03010104
EMDN description: INFUSION MICRO-CONTROLLERS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 16:51

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06192493100955

Chambre de compte-goutte Avec ou sans régulateurs, Embout: de forme variable

Class IIaMDR 2017/745Not intended for EU marketContains latexSingle useSterile

Manufacturer: Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd
Manufacturer SRN: TN-MF-000023623
UDI-DI: 06192493100955
Basic UDI-DI: 61924931TRANSFUSEURNU
Reference: TSCA22LLCC
EMDN: A03010102
EMDN description: INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 16:51

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Perfuseus à usage unique

les variants ;Chambre de goutement,tubulure,embout

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd
Manufacturer SRN: TN-MF-000023623
UDI-DI: 06192493100887
Basic UDI-DI: 61924931PERFUSEURW7
Reference: PS2a23SLLA
EMDN: A03010103
EMDN description: INFUSION CONTROLLERS WITH FLOW REGULATOR
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

Irigator Practic 1000 ml

Irigator clisma

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: S.C. MEV-PLASTIC S.R.L.
Manufacturer SRN: RO-MF-000022689
UDI-DI: 05944759078055
Basic UDI-DI: 59447590786426349000039PC
Reference: 2
EMDN: A03040299
EMDN description: IRRIGATION KITS, SINGLE-USE - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:24

Manufacturer products View details

Mini Irigator Practic 125ml

Irigator

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: S.C. MEV-PLASTIC S.R.L.
Manufacturer SRN: RO-MF-000022689
UDI-DI: 05944759078017
Basic UDI-DI: 59447590786426349000046P9
Reference: 3
EMDN: A03040299
EMDN description: IRRIGATION KITS, SINGLE-USE - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:24

Manufacturer products View details

IRIGATOR DEEA

Class IMDR 2017/745On the marketAdministering medicineDirect marking

Manufacturer: SC MEDDO SRL
Manufacturer SRN: RO-MF-000018753
UDI-DI: 05944759042032
Basic UDI-DI: 5944759042000179IDSX
Reference: 8920
EMDN: A03040299
EMDN description: IRRIGATION KITS, SINGLE-USE - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:18

Manufacturer products View details

MINIIRIGATOR

Class IMDR 2017/745On the marketAdministering medicineDirect marking

Manufacturer: SC MEDDO SRL
Manufacturer SRN: RO-MF-000018753
UDI-DI: 05944759042018
Basic UDI-DI: 5944759042000049MINZ9
Reference: 2168
EMDN: A03040299
EMDN description: IRRIGATION KITS, SINGLE-USE - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:18

Manufacturer products View details

WATERFALL endoscopic irrigation pump

Class IIaMDR 2017/745On the marketActive device

Manufacturer: EMED SP. Z O. O. SP. K.
Manufacturer SRN: PL-MF-000012648
UDI-DI: 05907763205503
Basic UDI-DI: 59077632-TF8WATERFALL-9S
Reference: 020-100
EMDN: A03010299
EMDN description: IRRIGATION CONTROLLERS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:34

Manufacturer products View details

05907595122481

Single-Use Tubing Set (SUTS)

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Vimex Sp. z o.o.
Manufacturer SRN: PL-MF-000008668
UDI-DI: 05907595122481
Basic UDI-DI: 5907595122PV-5201SUTSB9
Reference: 5201-63
EMDN: A030499
EMDN description: ADMINISTRATION KITS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:23

Manufacturer products View details

05907595122474

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: Vimex Sp. z o.o.
Manufacturer SRN: PL-MF-000008668
UDI-DI: 05907595122474
Basic UDI-DI: 5907595122PV-5201SUPPAP
Reference: 5201-61
EMDN: A030499
EMDN description: ADMINISTRATION KITS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:23

Manufacturer products View details