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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products View details

Medikro Grip

M91227

Class IMDR 2017/745On the market

Manufacturer: Medikro Oy
Manufacturer SRN: FI-MF-000011841
UDI-DI: 06420099001018
Basic UDI-DI: 6420099M91227B4
Reference: M91227
EMDN: Z12150199
EMDN description: SPIROMETRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

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Medikro Duo

M9497

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Medikro Oy
Manufacturer SRN: FI-MF-000011841
UDI-DI: 06420099000868
Basic UDI-DI: 6420099M9497LW
Reference: M920
EMDN: Z12150101
EMDN description: CLINICAL/DIAGNOSTIC SPIROMETERS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

Medikro Primo

M9492

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Medikro Oy
Manufacturer SRN: FI-MF-000011841
UDI-DI: 06420099000851
Basic UDI-DI: 6420099M9492LL
Reference: M914
EMDN: Z12150101
EMDN description: CLINICAL/DIAGNOSTIC SPIROMETERS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

Medikro® Ambi

M9489

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Medikro Oy
Manufacturer SRN: FI-MF-000011841
UDI-DI: 06420099000844
Basic UDI-DI: 6420099M9489LX
Reference: M911
EMDN: Z12150199
EMDN description: SPIROMETRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

Medikro Pro

M9488

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Medikro Oy
Manufacturer SRN: FI-MF-000011841
UDI-DI: 06420099000837
Basic UDI-DI: 6420099M9488LV
Reference: M915
EMDN: Z12150101
EMDN description: CLINICAL/DIAGNOSTIC SPIROMETERS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

SpiroSafe Disposable Flow Transducers

M9256

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Medikro Oy
Manufacturer SRN: FI-MF-000011841
UDI-DI: 06420099000554
Basic UDI-DI: 6420099M9256L6
Reference: M9256-100
EMDN: Z12150185
EMDN description: SPIROMETRY INSTRUMENTS - CONSUMABLES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

06420099000295

M9264

Class IMDR 2017/745On the market

Manufacturer: Medikro Oy
Manufacturer SRN: FI-MF-000011841
UDI-DI: 06420099000295
Basic UDI-DI: 6420099M9264L5
Reference: M9264-WA, ref 720707
EMDN: Z12150185
EMDN description: SPIROMETRY INSTRUMENTS - CONSUMABLES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

06420099000288

M9253

Class IMDR 2017/745On the market

Manufacturer: Medikro Oy
Manufacturer SRN: FI-MF-000011841
UDI-DI: 06420099000288
Basic UDI-DI: 6420099M9253KY
Reference: M9253-WA-200, ref 703415
EMDN: Z12150185
EMDN description: SPIROMETRY INSTRUMENTS - CONSUMABLES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

06420099000165

M9474

Class IMDR 2017/745On the market

Manufacturer: Medikro Oy
Manufacturer SRN: FI-MF-000011841
UDI-DI: 06420099000165
Basic UDI-DI: 6420099M9474LJ
Reference: M91130
EMDN: Z12150199
EMDN description: SPIROMETRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

Medikro Spirometry Software

M9831

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Medikro Oy
Manufacturer SRN: FI-MF-000011841
UDI-DI: 06420099000066
Basic UDI-DI: 6420099M9831LL
Reference: M9831
EMDN: Z12150192
EMDN description: SPIROMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products Authorised representative products Authorised representative actors View details