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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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315 device results listed.

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PROBE COVER MC-EP2 (MC-EP2-E)

MC-EP2-E

Class IMDR 2017/745On the marketSingle use

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672107885
Basic UDI-DI: 40156721078869
Reference: MC-EP2-E
EMDN: V030180
EMDN description: BODY TEMPERATURE MEASURING DEVICES - ACCESSORIES
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

AC-ADAPTER-E1600 (HXA-AC-1300E)

HXA-AC-1300E

Class IMDR 2017/745On the marketActive device

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672107878
Basic UDI-DI: 40156721078767
Reference: HXA-AC-1300E
EMDN: Z129080
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

Gentle Temp 521 (MC-521-E)

MC-521-E

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672107809
Basic UDI-DI: 4015672107805R
Reference: MC-521-E
EMDN: V0301010299
EMDN description: DIGITAL THERMOMETERS - OTHER
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

Gentle Temp 520 (MC-520-E)

MC-520-E

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672107793
Basic UDI-DI: 40156721077968
Reference: MC-520-E
EMDN: V0301010299
EMDN description: DIGITAL THERMOMETERS - OTHER
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

GS CUFF SS (HXA-GCUFF-SSLB)

HXA-GCUFF-SSLB

Class IMDR 2017/745On the market

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672107267
Basic UDI-DI: 4015672107265K
Reference: HXA-GCUFF-SSLB
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

GS CUFF S (HXA-GCUFF-SLB)

HXA-GCUFF-SLB

Class IMDR 2017/745On the market

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672107250
Basic UDI-DI: 4015672107255H
Reference: HXA-GCUFF-SLB
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: Belgium
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

GS CUFF M (HXA-GCUFF-MLB)

HXA-GCUFF-MLB

Class IMDR 2017/745On the market

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672107243
Basic UDI-DI: 4015672107245F
Reference: Z1203020302
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: Italy
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

GS CUFF L (HXA-GCUFF-LLB)

HXA-GCUFF-LLB

Class IMDR 2017/745On the market

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672107236
Basic UDI-DI: 4015672107235D
Reference: HXA-GCUFF-LLB
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: Belgium
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

GS CUFF XL (HXA-GCUFF-XLLB)

HXA-GCUFF-XLLB

Class IMDR 2017/745On the market

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672107229
Basic UDI-DI: 4015672107225B
Reference: HXA-GCUFF-XLLB
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: Hungary
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

BF214 (HBF-214-EBW)

HBF-214-EBW

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672107045
Basic UDI-DI: 40156721070459
Reference: HBF-214-EBW
EMDN: Z12099001
EMDN description: BODY IMPEDANCE ANALYSERS
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

BF212 (HBF-212-EW)

HBF-212-EW

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672107038
Basic UDI-DI: 40156721070357
Reference: HBF-212-EW
EMDN: Z12099001
EMDN description: BODY IMPEDANCE ANALYSERS
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

HEM-RML30 (HEM-RML30-E)

HEM-RML30-E

Class IMDR 2017/745On the market

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672106963
Basic UDI-DI: 40156721069663
Reference: HEM-RML30-E
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

NE-C801 (NE-C801S-UK(V))

NE-C801S-UK(V)

Class IIaMDR 2017/745On the marketActive device

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672106604
Basic UDI-DI: 4015672106605E
Reference: NE-C801S-UK(V)
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Northern Ireland
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

Comp A.I.R. Pro NE-C900 (NE-C900-E)

NE-C900-E

Class IIaMDR 2017/745On the marketActive device

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672106499
Basic UDI-DI: 4015672106495S
Reference: NE-C900-E
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

NEB-NE-C801 (NE-C801S-E(V))

NE-C801S-E(V)

Class IIaMDR 2017/745On the marketActive device

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672105645
Basic UDI-DI: 4015672105645H
Reference: NE-C801S-E(V)
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

NEB-NE-C801KD (NE-C801S-KDE(V))

NE-C801S-KDE(V)

Class IIaMDR 2017/745On the marketActive device

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672105621
Basic UDI-DI: 4015672105625D
Reference: NE-C801S-KDE(V)
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

CM (HEM-CR24-RU)

HEM-CR24-RU

Class IMDR 2017/745On the market

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672105584
Basic UDI-DI: 4015672105585N
Reference: HEM-CR24-RU
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: Latvia
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

CL (HEM-CL24-RU)

HEM-CL24-RU

Class IMDR 2017/745Not intended for EU market

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672105577
Basic UDI-DI: 4015672105575L
Reference: HEM-CL24-RU
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: -
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

CS2 Small Cuff (HEM-CS24-E)

HEM-CS24-E

Class IMDR 2017/745On the market

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672105553
Basic UDI-DI: 4015672105555G
Reference: CS2 Small Cuff (HEM-CS24-E)
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

Probe Cover (MC-PP100-E)

MC-PP100-E

Class IMDR 2017/745On the marketSingle use

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672105294
Basic UDI-DI: 4015672105295F
Reference: MC-PP100-E
EMDN: V030180
EMDN description: BODY TEMPERATURE MEASURING DEVICES - ACCESSORIES
First on market country: Finland
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:43

Manufacturer products Authorised representative products Authorised representative actors View details