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Ambistik PFT

Ambient sensor

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Geratherm Respiratory GmbH
Manufacturer SRN: DE-MF-000006818
UDI-DI: 04065803301002
Basic UDI-DI: 4065803301GR04ABQL
Reference: 654063
EMDN: Z12159080
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:47

Manufacturer products View details

Ambistik

Ambient Sensor

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Geratherm Respiratory GmbH
Manufacturer SRN: DE-MF-000006818
UDI-DI: 04065803300005
Basic UDI-DI: 4065803300GR04AAPZ
Reference: 634247
EMDN: Z12159080
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:47

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Diffustik

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Geratherm Respiratory GmbH
Manufacturer SRN: DE-MF-000006818
UDI-DI: 04065803203009
Basic UDI-DI: 4065803203GR03ADQW
Reference: 913857
EMDN: Z12159003
EMDN description: DIFFUSION ANALYSIS EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:47

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Add-on CO Diffusion

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Geratherm Respiratory GmbH
Manufacturer SRN: DE-MF-000006818
UDI-DI: 04065803202002
Basic UDI-DI: 4065803202GR03ACQB
Reference: 259149
EMDN: Z12159003
EMDN description: DIFFUSION ANALYSIS EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:47

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Spiraflow & Softclip Set

Flow sensor and noseclip

Class IMDR 2017/745On the market

Manufacturer: Geratherm Respiratory GmbH
Manufacturer SRN: DE-MF-000006818
UDI-DI: 04065803003005
Basic UDI-DI: 4065803003GR01JAPT
Reference: 340968
EMDN: Z12150185
EMDN description: SPIROMETRY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:47

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PFTstik

Pulmonary Function Testing device

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Geratherm Respiratory GmbH
Manufacturer SRN: DE-MF-000006818
UDI-DI: 04065803201012
Basic UDI-DI: 4065803201GR03ABPQ
Reference: 131710
EMDN: Z12159003
EMDN description: DIFFUSION ANALYSIS EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:47

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Bodystik

Bodyplethysmograph

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Geratherm Respiratory GmbH
Manufacturer SRN: DE-MF-000006818
UDI-DI: 04065803200008
Basic UDI-DI: 4065803200GR03AAP5
Reference: 785155
EMDN: Z12159007
EMDN description: BODY PLETHYSMOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:47

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Ergostik

Cardiopulmonary exercise system

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Geratherm Respiratory GmbH
Manufacturer SRN: DE-MF-000006818
UDI-DI: 04065803100001
Basic UDI-DI: 4065803100GR02AAN9
Reference: 618751
EMDN: Z12159099
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:47

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Spirostik Blue

Wireless Spirometer using Bluetooth 2.0

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Geratherm Respiratory GmbH
Manufacturer SRN: DE-MF-000006818
UDI-DI: 04065803002008
Basic UDI-DI: 4065803002GR01ACNK
Reference: 356246
EMDN: Z12150101
EMDN description: CLINICAL/DIAGNOSTIC SPIROMETERS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:47

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Spirostik

USB 2.0 Spirometer

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Geratherm Respiratory GmbH
Manufacturer SRN: DE-MF-000006818
UDI-DI: 04065803000004
Basic UDI-DI: 4065803000GR01AAMD
Reference: 361333
EMDN: Z12150101
EMDN description: CLINICAL/DIAGNOSTIC SPIROMETERS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:47

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iSpiro

iSpiro App

Class IMDR 2017/745On the marketActive device

Manufacturer: eResearchTechnology GmbH
Manufacturer SRN: DE-MF-000008015
UDI-DI: 04057155000658
Basic UDI-DI: 4057155Z12159082001KE
Reference: 1524xx
EMDN: Z12159082
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:35

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SpiroSphere

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: eResearchTechnology GmbH
Manufacturer SRN: DE-MF-000008015
UDI-DI: 04057155000351
Basic UDI-DI: 4057155Z12150101003C7
Reference: 707400
EMDN: Z12150101
EMDN description: CLINICAL/DIAGNOSTIC SPIROMETERS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:35

Manufacturer products View details

iSpiro Ultrasonic Sensor

Class IIaMDR 2017/745On the marketActive device

Manufacturer: eResearchTechnology GmbH
Manufacturer SRN: DE-MF-000008015
UDI-DI: 04057155000795
Basic UDI-DI: 4057155Z12150101004C9
Reference: 707115
EMDN: Z12150101
EMDN description: CLINICAL/DIAGNOSTIC SPIROMETERS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 20:35

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AM3

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: eResearchTechnology GmbH
Manufacturer SRN: DE-MF-000008015
UDI-DI: 04057155000191
Basic UDI-DI: 4057155Z12150102001CA
Reference: 1414xx
EMDN: Z12150102
EMDN description: PEAK FLOW SPIROMETERS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:35

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MasterScope

Class IIaMDR 2017/745On the marketActive device

Manufacturer: eResearchTechnology GmbH
Manufacturer SRN: DE-MF-000008015
UDI-DI: 04057155000023
Basic UDI-DI: 4057155Z12150101001C3
Reference: 171400, 171410
EMDN: Z12150101
EMDN description: CLINICAL/DIAGNOSTIC SPIROMETERS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 20:35

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04048551225240

Aspirators

Class IMDR 2017/745On the market

Manufacturer: KARL STORZ SE & Co. KG
Manufacturer SRN: DE-MF-000005723
UDI-DI: 04048551225240
Basic UDI-DI: 4048551000132SW
Reference: 10432N
EMDN: Z12159009
EMDN description: EQUIPMENT FOR REMOVAL OF SECRETIONS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:27

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04048551048771

Atomizes, ear surgery, metal

Class IMDR 2017/745On the market

Manufacturer: KARL STORZ SE & Co. KG
Manufacturer SRN: DE-MF-000005723
UDI-DI: 04048551048771
Basic UDI-DI: 4048551000350TA
Reference: 10456C
EMDN: Z12159002
EMDN description: AEROSOL EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:23

Manufacturer products View details

04048551048740

Atomizers, bronchoscopy

Class IMDR 2017/745On the market

Manufacturer: KARL STORZ SE & Co. KG
Manufacturer SRN: DE-MF-000005723
UDI-DI: 04048551048740
Basic UDI-DI: 4048551000136T6
Reference: 10454
EMDN: Z12159002
EMDN description: AEROSOL EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:23

Manufacturer products View details

03858893574767

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: Awatar Medical Aid d.o.o.
Manufacturer SRN: HR-MF-000025777
UDI-DI: 03858893574767
Basic UDI-DI: 385889357AWOX0016J
Reference: AW OXC001 10.S
EMDN: Z12159004
EMDN description: OXYGEN CONCENTRATORS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 17:35

Manufacturer products View details

MESI mTABLET SPIRO diagnostic system

MTABSYSSPIRO EN

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: MESI, razvoj medicinskih naprav, d.o.o.
Manufacturer SRN: SI-MF-000007761
UDI-DI: 03830059851660
Basic UDI-DI: 383005985MTABSYSSPIRORR
Reference: 301-004300
EMDN: Z12150101
EMDN description: CLINICAL/DIAGNOSTIC SPIROMETERS
First on market country: Slovenia
Authorised representative: -
Last updated: 01.07.2026 16:29

Manufacturer products View details