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MINI HMEF

Humidification Systems

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GVS Filter Technology UK Limited
Manufacturer SRN: UK-MF-000045036
UDI-DI: 05060120957078
Basic UDI-DI: 506012095Cat175
Reference: 9066/711ZAUA001/0001
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: Italy
Authorised representative: GVS S.p.A.
Last updated: 17.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

ISO GARD FILTER S WITH EXPANDI-FLEX / ELBOW NON MOUNTED WITH TETHERED CAP

19012T

Class IIaMDDOn the marketSingle use

Manufacturer: Teleflex Medical Sdn. Bhd.
Manufacturer SRN: MY-MF-000024692
UDI-DI: 04026704400423
Basic UDI-DI: B-04026704400423
Reference: 19012T
EMDN: R040101
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Ireland
Authorised representative: Teleflex Medical
Last updated: 16.07.2026 14:42

Manufacturer products Authorised representative products Authorised representative actors View details

HUMID VENT FILTER SMALL A WITH EXPANDI FLEX MOUNTED ON DRYSIDE

18602

Class IIaMDDOn the marketSingle use

Manufacturer: Teleflex Medical Sdn. Bhd.
Manufacturer SRN: MY-MF-000024692
UDI-DI: 04026704388301
Basic UDI-DI: B-04026704388301
Reference: 18602
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: Ireland
Authorised representative: Teleflex Medical
Last updated: 16.07.2026 14:42

Manufacturer products Authorised representative products Authorised representative actors View details

HUMID-VENT FILTER PEDI, STERILE

11011

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Teleflex Medical Sdn. Bhd.
Manufacturer SRN: MY-MF-000024692
UDI-DI: 04026704347834
Basic UDI-DI: B-04026704347834
Reference: 11011
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: Ireland
Authorised representative: Teleflex Medical
Last updated: 16.07.2026 14:42

Manufacturer products Authorised representative products Authorised representative actors View details

SpiroDef Mouthpiece with NoseClip

SpiroDef Filter

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Ganshorn Medizin Electronic GmbH
Manufacturer SRN: DE-MF-000006566
UDI-DI: 07613365500196
Basic UDI-DI: 7613365SPDEF32
Reference: 019420664
EMDN: R049001
EMDN description: PULMONARY FUNCTION TEST FILTERS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 11:38

Manufacturer products View details

Disposable Breathing Filter

HMEF

Class IIaMDR 2017/745Not intended for EU marketDirect markingSingle useSterile

Manufacturer: Shaoxing Undis Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000002187
UDI-DI: 16970531332103
Basic UDI-DI: 697053133hbfVX
Reference: HMEF-02
EMDN: R040101
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

HMEF, Luer Lid with Expandable Tube

Humidification Systems

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GVS Filter Technology UK Limited
Manufacturer SRN: UK-MF-000045036
UDI-DI: 05060120954916
Basic UDI-DI: 506012095Cat175
Reference: 4333/01DFKBAUA001/0001
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: Italy
Authorised representative: GVS S.p.A.
Last updated: 16.07.2026 09:48

Manufacturer products Authorised representative products Authorised representative actors View details

Spiroguard Re-usable

Respiratory Filters - Various

Class IIaMDR 2017/745On the market

Manufacturer: GVS Filter Technology UK Limited
Manufacturer SRN: UK-MF-000045036
UDI-DI: 05060120954237
Basic UDI-DI: 506012095Cat277
Reference: 2800/R2BAUA001/0001
EMDN: R049001
EMDN description: PULMONARY FUNCTION TEST FILTERS
First on market country: Italy
Authorised representative: GVS S.p.A.
Last updated: 16.07.2026 09:48

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable 22mm Bacterial/Viral Filter 22mm ID x 15mm ID/22mm OD

BV Filters

Class IMDR 2017/745On the marketSingle use

Manufacturer: Ventlab
Manufacturer SRN: US-MF-000008625
UDI-DI: 30889483095137
Basic UDI-DI: 0889483TF20005aBVFilterJH
Reference: FH603003
EMDN: R040101
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Humivent

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Engin Medikal Tıbbi Malzeme San Ve Tic Ltd Şti.
Manufacturer SRN: TR-MF-000050089
UDI-DI: 08685111288305
Basic UDI-DI: 086851112883VENTVN
Reference: 3530
EMDN: R040201
EMDN description: TRACHEOSTOMY HUMIDIFIERS
First on market country: Türkiye
Authorised representative: -
Last updated: 16.07.2026 07:04

Manufacturer products View details

SpeakFree HME ClassicFlow, 30 pack

SPEAKFREE

Class IMDR 2017/745On the marketSingle use

Manufacturer: Freudenberg Medical LLC
Manufacturer SRN: US-MF-000023823
UDI-DI: 00848253002200
Basic UDI-DI: 08482530SPEAKFREEGJ
Reference: BE 1090EZ
EMDN: R040201
EMDN description: TRACHEOSTOMY HUMIDIFIERS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Blom-Singer Day&Night ClassicFlow

DAY&NIGHT

Class IMDR 2017/745On the marketSingle use

Manufacturer: Freudenberg Medical LLC
Manufacturer SRN: US-MF-000023823
UDI-DI: 00848253002071
Basic UDI-DI: 08482530DAY&NIGHTVZ
Reference: BE 1091
EMDN: R040201
EMDN description: TRACHEOSTOMY HUMIDIFIERS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

HVT 2.0

Class IIaMDR 2017/745On the marketActive deviceAdministering medicineDirect marking

Manufacturer: Vapotherm Inc.
Manufacturer SRN: US-MF-000006231
UDI-DI: 00841737103219
Basic UDI-DI: 0841737102021UN
Reference: HVT20-UNIT
EMDN: R040201
EMDN description: TRACHEOSTOMY HUMIDIFIERS
First on market country: Austria
Authorised representative: AJW Technology Consulting GmbH
Last updated: 16.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details

10884521829176

Mechanical Filter HME (Non-Sterile)

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521829176
Basic UDI-DI: 0763000B00026037Y
Reference: 354U5876
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 16.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

10884521829060

Mechanical Filter HME (Sterile)

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Covidien llc
Manufacturer SRN: US-MF-000028763
UDI-DI: 10884521829060
Basic UDI-DI: 0763000B000148387
Reference: 354/5902
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 16.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

Vstupní vzduchový filtr HEPA

2080596K19Z000

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675697725
Basic UDI-DI: 0404867512080596K19Z000YS
Reference: MP12020
EMDN: R040101
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:57

Manufacturer products View details

Filter/HME TwinStar HEPA Plus

2080436K19S060

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675665823
Basic UDI-DI: 0404867512080436K19S060SL
Reference: MP05801
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:57

Manufacturer products View details

Filter/HME TwinStar 90 Plus

2080436K19S050

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675665809
Basic UDI-DI: 0404867512080436K19S050SH
Reference: MP05800
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:57

Manufacturer products View details

Filter CareStar 35 Plus

2080436K19S030

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675665724
Basic UDI-DI: 0404867512080436K19S030SB
Reference: MP05755
EMDN: R040101
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:57

Manufacturer products View details

HME HumidStar 55 Plus

2080436K19Z000

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675665663
Basic UDI-DI: 0404867512080436K19Z000TK
Reference: MP05730
EMDN: R040102
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 23:57

Manufacturer products View details