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EUDAMED Device Search

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Lullaby LED Phototherapy System

2052663-001

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682117401
Basic UDI-DI: 8406821BUG00395HY
Reference: 2052663-001
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:55

Manufacturer products Authorised representative products Authorised representative actors View details

Giraffe Incubator Carestation CS1

2082844-002

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682116855
Basic UDI-DI: 8406821BUG00377HW
Reference: 2082844-002
EMDN: Z1208040302
EMDN description: MOBILE NEONATAL INCUBATORS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:55

Manufacturer products Authorised representative products Authorised representative actors View details

Giraffe Omnibed Carestation CS1

2082844-001

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682116862
Basic UDI-DI: 8406821BUG00378HY
Reference: 2082844-001
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:55

Manufacturer products Authorised representative products Authorised representative actors View details

Giraffe Shuttle

2094632-001

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682110808
Basic UDI-DI: 8406821BUG00392HS
Reference: 2094632-001
EMDN: Z12080499
EMDN description: NEONATOLOGY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:55

Manufacturer products Authorised representative products Authorised representative actors View details

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

TRANSDUCER BELT – BUTTON - SINGLE PATIENT USE – 10/Box

Transducer Belt

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Wipro GE Healthcare Private Ltd
Manufacturer SRN: IN-MF-000016100
UDI-DI: 00840682142724
Basic UDI-DI: 8406821BUG00129H9
Reference: 2015827-001
EMDN: Z1208010485
EMDN description: CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

TOCO TRANSDUCER WATERTIGHT BUTTON

TOCO Transducer

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Wipro GE Healthcare Private Ltd
Manufacturer SRN: IN-MF-000016100
UDI-DI: 00840682104111
Basic UDI-DI: 8406821BUG00130GS
Reference: 2264HAX
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 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

Caress Flow

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: CARESS FLOW Srl
Manufacturer SRN: IT-MF-000040992
UDI-DI: 08057760160002
Basic UDI-DI: 805776016CF00AT
Reference: Caress Flow
EMDN: Z120899
EMDN description: GYNAECOLOGY AND MATERNAL-INFANTS INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:51

Manufacturer products View details

Bragagnolo Argenti

Proteggi Capezzoli in argento puro 999‰

Class IMDR 2017/745On the market

Manufacturer: Bragagnolo Argenti s.r.l.
Manufacturer SRN: IT-MF-000027957
UDI-DI: 08056646070350
Basic UDI-DI: 805664607SFLRK8
Reference: SFLR01
EMDN: Z12080399
EMDN description: VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:20

Manufacturer products View details

Bragagnolo Argenti

TRSFLR01

Class IMDR 2017/745On the market

Manufacturer: Bragagnolo Argenti s.r.l.
Manufacturer SRN: IT-MF-000027957
UDI-DI: 08056646070077
Basic UDI-DI: 805664607TRSFLRTA
Reference: TRSFLR01
EMDN: Z12080399
EMDN description: VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:20

Manufacturer products View details

SHARON 2.0

Class IMDR 2017/745On the marketDirect marking

Manufacturer: FAVERO HEALTH PROJECTS S.p.A.
Manufacturer SRN: IT-MF-000030368
UDI-DI: 08055728120105
Basic UDI-DI: 805572812FSSHR0013C
Reference: MANY
EMDN: Z12080499
EMDN description: NEONATOLOGY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 10:45

Manufacturer products View details

PIANI FASCIATOIO ZEROFIRE

Class IMDR 2017/745On the marketDirect marking

Manufacturer: FAVERO HEALTH PROJECTS S.p.A.
Manufacturer SRN: IT-MF-000030368
UDI-DI: 08055728120099
Basic UDI-DI: 805572812PNFSTZF0DV
Reference: MANY
EMDN: Z12080499
EMDN description: NEONATOLOGY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 10:45

Manufacturer products View details

NIDO Baby Crib

Class IMDR 2017/745On the marketDirect marking

Manufacturer: GINEVRI srl
Manufacturer SRN: IT-MF-000034527
UDI-DI: 08053847360105
Basic UDI-DI: 80538473602SC
Reference: 8036
EMDN: Z12080499
EMDN description: NEONATOLOGY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:53

Manufacturer products View details

BABY02

Bilance medicali digitali WU150

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: WUNDER SA.BI. S.R.L.
Manufacturer SRN: IT-MF-000028482
UDI-DI: 08052570460069
Basic UDI-DI: 805257046WU150AT
Reference: 000482C
EMDN: Z12080402
EMDN description: NEONATAL SCALES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:31

Manufacturer products View details

Carevix

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: ASPIVIX SA
Manufacturer SRN: CH-MF-000026572
UDI-DI: 07649995423079
Basic UDI-DI: 7649995423P03MH
Reference: P03-001-001-A1
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

07649991187012

Airborne TIS

Class IIbMDR 2017/745On the marketNo EU rep

Manufacturer: International Biomedical AG
Manufacturer SRN: CH-PR-000040281
UDI-DI: 07649991187012
Basic UDI-DI: 7649991187TISRW
Reference: 050-7320000
EMDN: Z1208040302
EMDN description: MOBILE NEONATAL INCUBATORS
First on market country: -
Authorised representative: -
Last updated: 03.07.2026 06:51

Manufacturer products View details