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Oxygen concentrator

OCB-5,OCB-5R

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005776
UDI-DI: 06942820422348
Basic UDI-DI: 69428204OXCTWS
Reference: OCB-5
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:39

Manufacturer products Authorised representative products Authorised representative actors View details

Medical Oxygen Concentrator

AR-3-N,AR-5-N

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: SHENYANG AERTI TECH CO.,LTD.
Manufacturer SRN: CN-MF-000014272
UDI-DI: 06922546700166
Basic UDI-DI: 692254670024FM
Reference: AR-3-N
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

06922546700074

AE-3,AE-3-S,AE-3-W,AE-5,AE-5-S,AE-5-W,AE-8,AE-8-S,AE-8-W

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: SHENYANG AERTI TECH CO.,LTD.
Manufacturer SRN: CN-MF-000014272
UDI-DI: 06922546700074
Basic UDI-DI: 692254670014FJ
Reference: AE-5
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 18:15

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06922546700067

AE-3-N,AE-3-NW,AE-5-N,AE-5-NW,AE-8-N,AE-8-NW

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: SHENYANG AERTI TECH CO.,LTD.
Manufacturer SRN: CN-MF-000014272
UDI-DI: 06922546700067
Basic UDI-DI: 692254670015FL
Reference: AE-3-N
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 18:15

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Medical Oxygen Concentrator

AR-3,AR-5

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: SHENYANG AERTI TECH CO.,LTD.
Manufacturer SRN: CN-MF-000014272
UDI-DI: 06922546700005
Basic UDI-DI: 692254670005FH
Reference: AR-3
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 18:15

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Ventica Electrodes

IPEL01

Class IMDR 2017/745On the marketSingle use

Manufacturer: Icare Finland Oy
Manufacturer SRN: FI-MF-000000501
UDI-DI: 06430033850879
Basic UDI-DI: 643003385IPEL0138
Reference: IPEL01
EMDN: Z12159085
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

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BIOSYNEX

Szájjal szívható orrszívó

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Rokána Kft.
Manufacturer SRN: HU-MF-000048032
UDI-DI: 05998177100010
Basic UDI-DI: 59981771000000000000001DX
Reference: 859077
EMDN: Z12159009
EMDN description: EQUIPMENT FOR REMOVAL OF SECRETIONS
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 16:35

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SALIN

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: TEHNO BIONIC SRL
Manufacturer SRN: RO-MF-000021063
UDI-DI: 05944759062139
Basic UDI-DI: 594475906206032000SALINJJ
Reference: SN-SP
EMDN: Z12159002
EMDN description: AEROSOL EQUIPMENT
First on market country: Czechia
Authorised representative: -
Last updated: 31.07.2026 16:22

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System ergospirometrii z bieżnią ergosprint z podtrzymaniem

BLUECHERRY13

Class IIbMDR 2017/745On the market

Manufacturer: Reynolds Medical spółka z ograniczoną odpowiedzialnością
Manufacturer SRN: PL-PR-000002806
UDI-DI: 05903771900003
Basic UDI-DI: 59037719BLUECHERRY1327
Reference: RMS.BC13.3
EMDN: Z12159006
EMDN description: EXPIRATED GAS ANALYSERS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 13:09

Manufacturer products View details

05099169916104

9160

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Vitalograph (Ireland) Limited
Manufacturer SRN: IE-MF-000004858
UDI-DI: 05099169916104
Basic UDI-DI: 50991699160UM
Reference: 91610
EMDN: Z12159007
EMDN description: BODY PLETHYSMOGRAPHS
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 09:21

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05099169332157

9100

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Vitalograph (Ireland) Limited
Manufacturer SRN: IE-MF-000004858
UDI-DI: 05099169332157
Basic UDI-DI: 50991699100U3
Reference: 91510
EMDN: Z12159003
EMDN description: DIFFUSION ANALYSIS EQUIPMENT
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 09:21

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05099169204089

2040

Class IMDR 2017/745On the market

Manufacturer: Vitalograph (Ireland) Limited
Manufacturer SRN: IE-MF-000004858
UDI-DI: 05099169204089
Basic UDI-DI: 50991692040SR
Reference: 20408
EMDN: Z12159080
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 09:21

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Clearway 2 Internal Battery

Clearway 2 Class I Accessories

Class IMDR 2017/745No longer on the marketActive device

Manufacturer: Breas Medical Limited
Manufacturer SRN: GB-MF-000003511
UDI-DI: 05060405721875
Basic UDI-DI: 5060405720189998D
Reference: 008283
EMDN: Z12159080
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Sweden
Authorised representative: Breas Medical AB
Last updated: 31.07.2026 08:43

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Gastrolyzer

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Bedfont Scientific Ltd
Manufacturer SRN: GB-MF-000010889
UDI-DI: 05060246860368
Basic UDI-DI: 506024686GC013B
Reference: GASTROCHECK UK
EMDN: Z12159006
EMDN description: EXPIRATED GAS ANALYSERS
First on market country: Slovakia
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

05060246860177

NObreath

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Bedfont Scientific Ltd
Manufacturer SRN: GB-MF-000010889
UDI-DI: 05060246860177
Basic UDI-DI: 506024686NO016Q
Reference: NOBREATH-V2
EMDN: Z12159006
EMDN description: EXPIRATED GAS ANALYSERS
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

Gastro+

Gastrolyzer

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Bedfont Scientific Ltd
Manufacturer SRN: GB-MF-000010889
UDI-DI: 05060246860108
Basic UDI-DI: 506024686GG013X
Reference: GASTRO
EMDN: Z12159006
EMDN description: EXPIRATED GAS ANALYSERS
First on market country: Hungary
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

Peak Flow Meter

Class IMDR 2017/745On the marketMeasuring function

Manufacturer: Medicareplus International Limited
Manufacturer SRN: GB-MF-000011921
UDI-DI: 05060092860482
Basic UDI-DI: 506009286PFM0012E
Reference: 60482
EMDN: Z12159085
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:27

Manufacturer products Authorised representative products Authorised representative actors View details

Flutter

Class IMDR 2017/745On the market

Manufacturer: Flexicare Medical Limited
Manufacturer SRN: GB-MF-000034163
UDI-DI: 05023323001603
Basic UDI-DI: 50233232201587926
Reference: 3102000
EMDN: Z12159009
EMDN description: EQUIPMENT FOR REMOVAL OF SECRETIONS
First on market country: Northern Ireland
Authorised representative: Flexicare EU Ops Ltd
Last updated: 31.07.2026 07:53

Manufacturer products Authorised representative products Authorised representative actors View details

Asthma Optimiser

Treatment Optimiser

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Lothar Medtec GmbH
Manufacturer SRN: DE-MF-000007469
UDI-DI: 04270001023551
Basic UDI-DI: 42700010235TOR2
Reference: Asthma Optimiser
EMDN: Z12159092
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:46

Manufacturer products View details

ALDS

ALDS Hardware Accessories

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Lothar Medtec GmbH
Manufacturer SRN: DE-MF-000007469
UDI-DI: 04262466450041
Basic UDI-DI: 42700010235ALDS-ACCS8P
Reference: ALDS
EMDN: Z12159080
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:46

Manufacturer products View details