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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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88 device results listed.

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Panda iRes Warmer

M1112198

Class IIbMDR 2017/745On the marketActive deviceAdministering medicineDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682103893
Basic UDI-DI: 8406821BUG00390HN
Reference: M1112198
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:53

Manufacturer products Authorised representative products Authorised representative actors View details

Giraffe Stand-alone Infant Resuscitation System T-Piece

Giraffe Stand-alone Infant Resuscitation System

Class IIbMDR 2017/745On the marketActive deviceAdministering medicineDirect markingMeasuring function

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682100151
Basic UDI-DI: 8406821BUG00396J2
Reference: 2082663-001
EMDN: Z12080499
EMDN description: NEONATOLOGY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:53

Manufacturer products Authorised representative products Authorised representative actors View details

Novii+ Pod

Novii+ Wireless Patch System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00195278115171
Basic UDI-DI: 8406821BUG00458HX
Reference: 5514130
EMDN: Z1208010403
EMDN description: TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Giraffe Blue Spot PT Lite

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00195278022233
Basic UDI-DI: 8406821BUG00394HW
Reference: M1238506
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Türkiye
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Novii Patch

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 15060433670074
Basic UDI-DI: 8406821BUG00146H9
Reference: 107-PT-004
EMDN: Z1208010485
EMDN description: CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details

Pressure Diffusing Mattress

2076066-001

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682146869
Basic UDI-DI: 8406821BUG00158HG
Reference: 2076066-001
EMDN: V028099
EMDN description: NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details

Lullaby Reusable Infant Temperature Probe

2044384-001

Class IMDR 2017/745On the market

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682144025
Basic UDI-DI: 8406821BUG00184HH
Reference: 2044384-001
EMDN: V03010201
EMDN description: TEMPERATURE MONITORING CUTANEOUS PROBES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details

Lullaby IV Pole

IV Pole

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682142649
Basic UDI-DI: 8406821BUG00128H7
Reference: 2041600-001
EMDN: Z12030380
EMDN description: INFUSION INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

Novii+ Interface

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00195278212313
Basic UDI-DI: 8406821BUG00458HX
Reference: 5514131
EMDN: Z1208010403
EMDN description: TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 29.06.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

Giraffe Blue Spot PT Lite

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00195278265074
Basic UDI-DI: 8406821BUG00394HW
Reference: M1236303
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 29.06.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

NOVII INTERFACE CABLE - GE MECG

Class INot specifiedOn the marketDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 05060433670114
Basic UDI-DI: 8406821BUG00136H6
Reference: 105-PT-104
EMDN: Z1208010480
EMDN description: CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 25.06.2026 05:41

Manufacturer products Authorised representative products Authorised representative actors View details

NOVII INTERFACE CABLE - GE UA

Class INot specifiedOn the marketDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 05060433670138
Basic UDI-DI: 8406821BUG00136H6
Reference: 105-PT-106
EMDN: Z1208010480
EMDN description: CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 25.06.2026 05:41

Manufacturer products Authorised representative products Authorised representative actors View details

Giraffe Stand-alone Infant Resuscitation System Bag and Mask

Class IIbMDR 2017/745On the marketActive deviceAdministering medicineDirect markingMeasuring function

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682100175
Basic UDI-DI: 8406821BUG00396J2
Reference: 2082663-002
EMDN: Z12080499
EMDN description: NEONATOLOGY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 22.06.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

Giraffe Blue Spot PT Lite

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682116541
Basic UDI-DI: 8406821BUG00394HW
Reference: M1231533
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 22.06.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

Giraffe Blue Spot PT Lite

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682116572
Basic UDI-DI: 8406821BUG00394HW
Reference: M1224917
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 22.06.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

Lullaby Resus Plus – NIST

Class IIbMDR 2017/745On the marketActive deviceAdministering medicineDirect markingMeasuring function

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682142748
Basic UDI-DI: 8406821BUG00397J4
Reference: 2070100-001
EMDN: Z12080499
EMDN description: NEONATOLOGY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 22.06.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

Lullaby Warmer - WARMER MAIN ASM, 115V for sea shipment

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682142762
Basic UDI-DI: 8406821BUG00391HQ
Reference: 2061755-001
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 22.06.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

Lullaby Warmer - Warmer main Assembly 115V

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682142779
Basic UDI-DI: 8406821BUG00391HQ
Reference: 2050878-001
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 22.06.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

Lullaby Warmer - Warmer Assembly 230 V for sea shipment

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682142786
Basic UDI-DI: 8406821BUG00391HQ
Reference: 2060092-001
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 22.06.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

Giraffe Blue Spot PT Lite

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682143493
Basic UDI-DI: 8406821BUG00394HW
Reference: M1225067
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 22.06.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details