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BTL SpiroAir

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Medisoft S.A.
Manufacturer SRN: BE-MF-000000789
UDI-DI: 05407003163025
Basic UDI-DI: B-05407003163025
Reference: SP-00-01-BTL
EMDN: Z12159008
EMDN description: PNEUMOTACHOGRAPHS
First on market country: Belgium
Authorised representative: -
Last updated: 06.07.2026 08:31

Manufacturer products View details

BTL BodyBox

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Medisoft S.A.
Manufacturer SRN: BE-MF-000000789
UDI-DI: 05407003160048
Basic UDI-DI: B-05407003160048
Reference: BB-00-01-BTL
EMDN: Z12150101
EMDN description: CLINICAL/DIAGNOSTIC SPIROMETERS
First on market country: Belgium
Authorised representative: -
Last updated: 06.07.2026 08:31

Manufacturer products View details

Blue Cherry

Class IIaMDDOn the marketMeasuring function

Manufacturer: Geratherm Respiratory GmbH
Manufacturer SRN: DE-MF-000006818
UDI-DI: 04065803400002
Basic UDI-DI: B-04065803400002
Reference: 598197
EMDN: Z12159092
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:37

Manufacturer products View details

PressurePod

625612

Class IIaMDDOn the marketActive deviceMeasuring functionSingle use

Manufacturer: Drägerwerk AG & Co. KGaA
Manufacturer SRN: DE-MF-000005329
UDI-DI: 04048675625612
Basic UDI-DI: B-04048675625612
Reference: 8424050
EMDN: Z12159099
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:02

Manufacturer products View details

A3 Complete (NE-C300-ITA)

NE-C300-ITA

Class IIaMDDOn the marketActive device

Manufacturer: 3A HEALTH CARE S.r.l.
Manufacturer SRN: IT-MF-000009298
UDI-DI: 04015672109674
Basic UDI-DI: B-04015672109674
Reference: NE-C300-ITA
EMDN: Z12159099
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 05.07.2026 22:42

Manufacturer products View details

A3 Complete (NE-C300-E)

NE-C300-E

Class IIaMDDOn the marketActive device

Manufacturer: 3A HEALTH CARE S.r.l.
Manufacturer SRN: IT-MF-000009298
UDI-DI: 04015672109407
Basic UDI-DI: B-04015672109407
Reference: NE-C300-E
EMDN: Z12159099
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 05.07.2026 22:42

Manufacturer products View details

BlueNight Trainer

Class IIaMDDOn the marketActive device

Manufacturer: SLEEPINNOV TECHNOLOGY
Manufacturer SRN: FR-MF-000016061
UDI-DI: 03770026864036
Basic UDI-DI: B-03770026864036
Reference: 1010001001
EMDN: Z12159092
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:33

Manufacturer products View details

SPINEO

Class IMDDOn the marketActive device

Manufacturer: NOVIGA
Manufacturer SRN: FR-MF-000004552
UDI-DI: 03760362960004
Basic UDI-DI: B-03760362960004
Reference: SPINEO-1.0
EMDN: Z12159092
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:19

Manufacturer products View details

Spirolyser Q13

Spirolyser Q13 Depisteo

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: FIM Medical
Manufacturer SRN: FR-MF-000017090
UDI-DI: 03760253450522
Basic UDI-DI: B-03760253450522
Reference: FF1153
EMDN: Z12150101
EMDN description: CLINICAL/DIAGNOSTIC SPIROMETERS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:53

Manufacturer products View details

Qflow

Class IIaMDDOn the marketSingle use

Manufacturer: FIM Medical
Manufacturer SRN: FR-MF-000017090
UDI-DI: 03760253450188
Basic UDI-DI: B-03760253450188
Reference: Qflow
EMDN: Z12150185
EMDN description: SPIROMETRY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:53

Manufacturer products View details

HORIZON

R41508

Class IIaMDDOn the marketActive deviceAdministering medicine

Manufacturer: SCALEO MEDICAL
Manufacturer SRN: FR-MF-000002929
UDI-DI: 03664844000076
Basic UDI-DI: B-03664844000076
Reference: R41508
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 17:41

Manufacturer products View details

Pack Horizon® P5 – 16 cells

R41516

Class IIaMDDOn the marketActive device

Manufacturer: SCALEO MEDICAL
Manufacturer SRN: FR-MF-000002929
UDI-DI: 03664844000069
Basic UDI-DI: B-03664844000069
Reference: R41516
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 17:41

Manufacturer products View details

SCALEO Medical

R4110020

Class IIaMDDOn the marketActive device

Manufacturer: SCALEO MEDICAL
Manufacturer SRN: FR-MF-000002929
UDI-DI: 03664844000038
Basic UDI-DI: B-03664844000038
Reference: R4110020
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 17:41

Manufacturer products View details

Live Active Five

PM4155

Class IIaMDDOn the marketActive deviceAdministering medicineMeasuring function

Manufacturer: Precision Medical Inc
Manufacturer SRN: US-MF-000008706
UDI-DI: 00855887006887
Basic UDI-DI: B-00855887006887
Reference: PM4155
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: Hungary
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

HurriChem

PDT-5500

Class IIbMDDOn the marketActive deviceAdministering medicineSingle useSterile

Manufacturer: ThermaSolutions Europe BV
Manufacturer SRN: NL-MF-000022782
UDI-DI: 00851450007213
Basic UDI-DI: B-00851450007213
Reference: PDT-5500
EMDN: Z12159002
EMDN description: AEROSOL EQUIPMENT
First on market country: Netherlands
Authorised representative: -
Last updated: 05.07.2026 11:14

Manufacturer products View details

SALIN

Class INot specifiedOn the marketDirect marking

Manufacturer: TEHNO BIONIC SRL
Manufacturer SRN: RO-MF-000021063
UDI-DI: 05944759062146
Basic UDI-DI: 594475906206032000SALINJJ
Reference: SALIN S2
EMDN: Z12159002
EMDN description: AEROSOL EQUIPMENT
First on market country: Romania
Authorised representative: -
Last updated: 05.07.2026 07:59

Manufacturer products View details

ULTRAFILL,230V,EU

UltraFill

Class IIbMDDNo longer on the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959032491
Basic UDI-DI: B-00606959032491
Reference: 1057124
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

Trilogy Active Flow Exhalation Circuit Adult

Trilogy Circuit Accessories

Class IIaMDDOn the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959005211
Basic UDI-DI: B-00606959005211
Reference: 1068837
EMDN: Z12150180
EMDN description: SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Mark 5 Nuvo Lite

925

Class IIaMDDOn the marketActive device

Manufacturer: Nidek Medical Products Inc.
Manufacturer SRN: US-MF-000007253
UDI-DI: 00038214000929
Basic UDI-DI: B-00038214000929
Reference: 925GC
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 04.07.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

SIH 09

Class IIaMDR 2017/745On the marketActive deviceAdministering medicineDirect marking

Manufacturer: Globalcare Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000033595
UDI-DI: 06970229252075
Basic UDI-DI: 697022925GCE8XXEM
Reference: 854.71
EMDN: Z12159002
EMDN description: AEROSOL EQUIPMENT
First on market country: -
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 03.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details