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MAXI Straight HMEF

Humidification Systems

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GVS Filter Technology UK Limited
Manufacturer SRN: UK-MF-000045036
UDI-DI: 05060120950277
Basic UDI-DI: 506012095Cat175
Reference: 4333/712BAUA001/0001
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: Italy
Authorised representative: GVS S.p.A.
Last updated: 04.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

ECO slimline

Respiratory Filters - Various

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GVS Filter Technology UK Limited
Manufacturer SRN: UK-MF-000045036
UDI-DI: 05060120950079
Basic UDI-DI: 506012095Cat277
Reference: 4222/01BAUA001/0001
EMDN: R040199
EMDN description: VENTILATION FILTERS - OTHER
First on market country: Italy
Authorised representative: GVS S.p.A.
Last updated: 04.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

30884522012618

Electrostatic Filter HME (Non-Sterile)

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 30884522012618
Basic UDI-DI: 0763000B00026027W
Reference: 352U5877
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 04.08.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

10884521837508

Electrostatic Filter (Sterile)

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521837508
Basic UDI-DI: 0763000B00021157E
Reference: 350/5845TC
EMDN: R040101
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 04.08.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

10884521078130

Mechanical Filter (Sterile)

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521078130
Basic UDI-DI: 0763000B00021167G
Reference: 351/5410Z
EMDN: R040101
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 04.08.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

ISO GARD HEPA SMALL

28062EU

Class IIaMDDOn the marketSingle use

Manufacturer: Teleflex Medical Sdn. Bhd.
Manufacturer SRN: MY-MF-000024692
UDI-DI: 14026704673138
Basic UDI-DI: B-14026704673138
Reference: 28062EU
EMDN: R040101
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Ireland
Authorised representative: Teleflex Medical
Last updated: 04.08.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

ISO-GARD HEPA Machine HME

Class IIaNot specifiedOn the marketSingle use

Manufacturer: Teleflex Medical Sdn. Bhd.
Manufacturer SRN: MY-MF-000024692
UDI-DI: 14026704673121
Basic UDI-DI: B-14026704673121
Reference: 28022EU
EMDN: R040101
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Ireland
Authorised representative: Teleflex Medical
Last updated: 04.08.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

ISO GARD HEPA LIGHT HME

28012EU

Class IIaMDDOn the marketSingle use

Manufacturer: Teleflex Medical Sdn. Bhd.
Manufacturer SRN: MY-MF-000024692
UDI-DI: 14026704673114
Basic UDI-DI: B-14026704673114
Reference: 28012EU
EMDN: R040101
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Ireland
Authorised representative: Teleflex Medical
Last updated: 04.08.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

ISO GARD HEPA LIGHT HME

28002EU

Class IIaMDDOn the marketSingle use

Manufacturer: Teleflex Medical Sdn. Bhd.
Manufacturer SRN: MY-MF-000024692
UDI-DI: 14026704673107
Basic UDI-DI: B-14026704673107
Reference: 28002EU
EMDN: R040101
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Ireland
Authorised representative: Teleflex Medical
Last updated: 04.08.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

10884521829121

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521829121
Basic UDI-DI: 0763000B000148285
Reference: 355/5814
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 04.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

10884521837478

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521837478
Basic UDI-DI: 0763000B000148285
Reference: 352/5996TC
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 04.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

10884521829084

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521829084
Basic UDI-DI: 0763000B000148285
Reference: 355/5430TC
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 04.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

10884521837461

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521837461
Basic UDI-DI: 0763000B000148285
Reference: 352/5877TC
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 04.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

10884521837492

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521837492
Basic UDI-DI: 0763000B000148285
Reference: 352/5877TCZ
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 04.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

10884521829091

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521829091
Basic UDI-DI: 0763000B000148285
Reference: 355/5430TCZ
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 04.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

10884521837485

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521837485
Basic UDI-DI: 0763000B000148285
Reference: 352/5867TC
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 04.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

10884522028097

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884522028097
Basic UDI-DI: 0763000B000148285
Reference: 352/5844
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 03.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

10884522028103

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884522028103
Basic UDI-DI: 0763000B000148285
Reference: 352/5855
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 03.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

10884521829077

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521829077
Basic UDI-DI: 0763000B000148285
Reference: 355/5430
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 03.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

10884521829114

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521829114
Basic UDI-DI: 0763000B000148285
Reference: 355/5430Z
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 03.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details