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EUDAMED Device Search

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

Last updated

06.07.2026 23:34

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Active filter:Manufacturer SRN:TW-MF-000004839

6 device results listed.

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Rooti

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370153
Basic UDI-DI: 471987337RootiCare8E
Reference: RootiCare
EMDN: Z12050892
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Rooti Rx Patch

Class IMDR 2017/745On the market

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370139
Basic UDI-DI: 471987337RootiRxPatchTH8
Reference: RXAP02
EMDN: Z12050880
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Wellkang Ltd
Last updated: 02.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Rooti Rx System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370092
Basic UDI-DI: 471987337RootiRxDJ
Reference: RXAP02, RXAP03, RXMD01, RXMD02, ASCD01
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

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Class INot specifiedOn the marketDirect markingSingle use

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370146
Basic UDI-DI: 471987337RootiRxPatchTH8
Reference: RXAP02-50
EMDN: Z12050880
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Wellkang Ltd
Last updated: 18.06.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

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Class IIaNot specifiedOn the marketDirect markingSingle use

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370122
Basic UDI-DI: 471987337RootiRxDJ
Reference: RXAP01-50
EMDN: Z12050880
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 18.06.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370115
Basic UDI-DI: 471987337RootiRxDJ
Reference: RXAP01
EMDN: Z12050880
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 18.06.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details