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00812432020484

BiliSoft 2.0 PT Systems, Small Pad, English, US Plug

Class IIaMDDOn the marketActive device

Manufacturer: Lumitex Medical Devices, Inc.
Manufacturer SRN: US-MF-000030520
UDI-DI: 00812432020484
Basic UDI-DI: B-00812432020484
Reference: 2106573-001
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Bilitron 7006

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Fanem Medical Devices India Private Limited
Manufacturer SRN: IN-MF-000039532
UDI-DI: 08908025930017
Basic UDI-DI: 8908025930B7006UX
Reference: FANEM-CTL-7006
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

Bilitron Sky 2006

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Fanem Medical Devices India Private Limited
Manufacturer SRN: IN-MF-000039532
UDI-DI: 08908025930000
Basic UDI-DI: 8908025930BS20064B
Reference: FANEM-CTL-2006
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

AVI/AVI Healthcare

Bilipod LED

Class IIaMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: AVI Healthcare Private Limited
Manufacturer SRN: IN-MF-000014676
UDI-DI: 08908022817038
Basic UDI-DI: 8908022817AVIBPLLPHV2
Reference: --
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

AVI/AVI Healthcare

IW4000

Class IIbMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: AVI Healthcare Private Limited
Manufacturer SRN: IN-MF-000014676
UDI-DI: 08908022817007
Basic UDI-DI: 8908022817AVINIW040RQ
Reference: --
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

08809933330015

Apnotrack

Class IMDR 2017/745On the market

Manufacturer: Asleep Inc
Manufacturer SRN: KR-MF-000054415
UDI-DI: 08809933330015
Basic UDI-DI: 880993333ApnoTrackEUP5
Reference: Apnotrack
EMDN: Z12080406
EMDN description: APNOEA MONITORS
First on market country: France
Authorised representative: SOAR & PARTNERS Sp. z o.o.
Last updated: 03.07.2026 21:05

Manufacturer products Authorised representative products Authorised representative actors View details

08809307611238

JW-Hi7000

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: JW Pharmaceutical Corporation
Manufacturer SRN: KR-MF-000030307
UDI-DI: 08809307611238
Basic UDI-DI: 88093076112388Q
Reference: JW-Hi7000
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

08809307611252

JW-i5000

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: JW Pharmaceutical Corporation
Manufacturer SRN: KR-MF-000030307
UDI-DI: 08809307611252
Basic UDI-DI: 88093076112528J
Reference: JW-i5000
EMDN: Z1208040301
EMDN description: FIXED NEONATAL INCUBATORS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

08809307611245

JW-i7000

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: JW Pharmaceutical Corporation
Manufacturer SRN: KR-MF-000030307
UDI-DI: 08809307611245
Basic UDI-DI: 88093076112458M
Reference: JW-i7000
EMDN: Z1208040301
EMDN description: FIXED NEONATAL INCUBATORS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Jauni

Jauni Wearable Phototherapy

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Bilihome B.V.
Manufacturer SRN: NL-MF-000025535
UDI-DI: 87208653770014
Basic UDI-DI: 8720865377PhototherapyY7
Reference: 230115.JSK
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 20:10

Manufacturer products View details

Concord Birth Trolley

CBT-0001 V3.x

Class IMDR 2017/745No longer on the market

Manufacturer: Concord Neonatal BV
Manufacturer SRN: NL-MF-000023247
UDI-DI: 08720299497603
Basic UDI-DI: 87202994976CBT-0001X2
Reference: CBT-0001
EMDN: Z12080405
EMDN description: NEONATAL RESUSCITATION BEDS
First on market country: -
Authorised representative: -
Last updated: 03.07.2026 19:48

Manufacturer products View details

EMSAŞ

EBI

Class IMDR 2017/745On the marketReusable

Manufacturer: EMSAŞ A.Ş.
Manufacturer SRN: TR-MF-000045722
UDI-DI: 08699975063015
Basic UDI-DI: 869997506EBI2R
Reference: EBI06
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:16

Manufacturer products View details

maviLed Phototherapy Device

30220

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ASTEKMED MEDIKAL IC VE DIS TIC AS
Manufacturer SRN: TR-MF-000018605
UDI-DI: 08695406000055
Basic UDI-DI: 8695406000PTP3
Reference: 30220
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:43

Manufacturer products View details

SCHRODER - BC 11 - BABY CODE

BC 11

Class IMDR 2017/745On the market

Manufacturer: PROMA MEDIKAL LTD ŞTI
Manufacturer SRN: TR-MF-000017590
UDI-DI: 8682139009486
Basic UDI-DI: 8682139009BCL3
Reference: BC 11
EMDN: Z1208040301
EMDN description: FIXED NEONATAL INCUBATORS
First on market country: Lithuania
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

INFANT PHOTOTHERAPEUTIC DEVICE

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: TSE spol. s r.o.
Manufacturer SRN: CZ-MF-000026442
UDI-DI: 08594216240432
Basic UDI-DI: 859421624FTL-620JX
Reference: FTL-620
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:51

Manufacturer products View details

Heated bed for newborns and infants VL-22

VL-22 / VL-22F

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: ALFAMEDIC s.r.o.
Manufacturer SRN: CZ-MF-000037764
UDI-DI: 08594201470011
Basic UDI-DI: 859420147VL22F001MT
Reference: VL-22F-S-B
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:41

Manufacturer products View details

Set Monitorización Brizzy 10P

Agrupaciones Apnea IIb

Class IIbMDR 2017/745On the market

Manufacturer: PRIM, S.A.
Manufacturer SRN: ES-PR-000004648
UDI-DI: 08434048533299
Basic UDI-DI: 843404825APNEAIIBVN
Reference: PL010
EMDN: Z12080406
EMDN description: APNOEA MONITORS
First on market country: -
Authorised representative: -
Last updated: 03.07.2026 13:37

Manufacturer products View details

Set Monitorización BRIZZY+10

Agrupaciones Apnea

Class IMDR 2017/745On the market

Manufacturer: PRIM, S.A.
Manufacturer SRN: ES-PR-000004648
UDI-DI: 08434048345588
Basic UDI-DI: 843404825APNEAAA
Reference: NS010
EMDN: Z12080406
EMDN description: APNOEA MONITORS
First on market country: -
Authorised representative: -
Last updated: 03.07.2026 13:36

Manufacturer products View details

Lullaby Warmer - Warmer Assembly 230 V

Lullaby Warmer

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682142663
Basic UDI-DI: 8406821BUG00391HQ
Reference: 2041599-001
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

Lullaby Resus Plus – DISS

Lullaby Resus Plus

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

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682142656
Basic UDI-DI: 8406821BUG00397J4
Reference: 2070100-002
EMDN: Z12080499
EMDN description: NEONATOLOGY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details