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Infant Radiant Warmer

W-300/W-500/W-600

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: DAVID MEDICAL EUROPE, UNIPESSOAL LDA
Manufacturer SRN: PT-MF-000042894
UDI-DI: 05600802300091
Basic UDI-DI: 560080230W-001RG
Reference: W-500
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 11:30

Manufacturer products View details

Transport Incubator

T-500/T-800

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: DAVID MEDICAL EUROPE, UNIPESSOAL LDA
Manufacturer SRN: PT-MF-000042894
UDI-DI: 05600802300077
Basic UDI-DI: 560080230T-001QF
Reference: T-800
EMDN: Z1208040302
EMDN description: MOBILE NEONATAL INCUBATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 11:30

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Infant Incubator

N-200/N-500/N-520/N-550/N-600

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: DAVID MEDICAL EUROPE, UNIPESSOAL LDA
Manufacturer SRN: PT-MF-000042894
UDI-DI: 05600802300015
Basic UDI-DI: 560080230N-001ND
Reference: N-500
EMDN: Z1208040301
EMDN description: FIXED NEONATAL INCUBATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 11:30

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Transcutaneous Jaundice Detector

D-100

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: DAVID MEDICAL EUROPE, UNIPESSOAL LDA
Manufacturer SRN: PT-MF-000042894
UDI-DI: 05600802300169
Basic UDI-DI: 560080230D-001JX
Reference: D-100
EMDN: Z12080410
EMDN description: TRANSCUTANEOUS BILIRUBINOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 11:25

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Neonate Bilirubin Phototherapy Equipment

P-200/P-300/P-500

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DAVID MEDICAL EUROPE, UNIPESSOAL LDA
Manufacturer SRN: PT-MF-000042894
UDI-DI: 05600802300114
Basic UDI-DI: 560080230P-001P3
Reference: P-200
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 11:25

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Infant Radiant Warmer

W-300/W-500/W-600

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: DAVID MEDICAL EUROPE, UNIPESSOAL LDA
Manufacturer SRN: PT-MF-000042894
UDI-DI: 05600802300084
Basic UDI-DI: 560080230W-001RG
Reference: W-300
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 11:25

Manufacturer products View details

Transport Incubator

T-500/T-800

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: DAVID MEDICAL EUROPE, UNIPESSOAL LDA
Manufacturer SRN: PT-MF-000042894
UDI-DI: 05600802300060
Basic UDI-DI: 560080230T-001QF
Reference: T-500
EMDN: Z1208040302
EMDN description: MOBILE NEONATAL INCUBATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 11:25

Manufacturer products View details

Infant Incubator

N-800

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: DAVID MEDICAL EUROPE, UNIPESSOAL LDA
Manufacturer SRN: PT-MF-000042894
UDI-DI: 05600802300053
Basic UDI-DI: 560080230N-002NF
Reference: N-800
EMDN: Z1208040301
EMDN description: FIXED NEONATAL INCUBATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 11:25

Manufacturer products View details

Infant Incubator

N-200/N-500/N-520/N-550/N-600

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: DAVID MEDICAL EUROPE, UNIPESSOAL LDA
Manufacturer SRN: PT-MF-000042894
UDI-DI: 05600802300008
Basic UDI-DI: 560080230N-001ND
Reference: N-200
EMDN: Z1208040301
EMDN description: FIXED NEONATAL INCUBATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 11:25

Manufacturer products View details

GROW 2.0

GROW Service

Class IMDR 2017/745On the marketActive device

Manufacturer: Perinatal Institute
Manufacturer SRN: UK-MF-000048417
UDI-DI: 15061102480000
Basic UDI-DI: 50611024GROWG8
Reference: GROW 2.0
EMDN: Z12080392
EMDN description: VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Europecert UG (haftungsbeschränkt)
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Gynaecology & Obstetrics

GYN 01

Class IMDR 2017/745On the marketSterile

Manufacturer: SYNDEO Medical
Manufacturer SRN: BE-PR-000044136
UDI-DI: 05065021834275
Basic UDI-DI: 5065021834SYNPP027ZK
Reference: SYN-GYN01-001
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 09:17

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Gynaecology & Obstetrics

GYN 02

Class IIaMDR 2017/745On the marketSterile

Manufacturer: SYNDEO Medical
Manufacturer SRN: BE-PR-000044136
UDI-DI: 05065021834060
Basic UDI-DI: 5065021834SYNPP006ZB
Reference: SYN-GYN02-001
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 09:17

Manufacturer products View details

FraiyaScan

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Fraiya Ltd
Manufacturer SRN: UK-MF-000045978
UDI-DI: 05061081480018
Basic UDI-DI: 5061081485061081480001Q5
Reference: FraiyaScan
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BACK WARMERS

AURACARE- BACK WARMERS

Class IMDR 2017/745On the market

Manufacturer: Fima Global Brands Ltd
Manufacturer SRN: UK-MF-000036604
UDI-DI: 05060982423308
Basic UDI-DI: 506098242ACW-0042B
Reference: ACW-004
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Hungary
Authorised representative: GLORY-Cosmetic Hungary Kft.
Last updated: 31.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

SONICAID

SRX

Class IIaMDR 2017/745On the marketActive device

Manufacturer: ArjoHuntleigh AB
Manufacturer SRN: SE-MF-000000696
UDI-DI: 05051968017277
Basic UDI-DI: 5060693520358WM
Reference: D920-P
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 08:51

Manufacturer products View details

Lansinoh Smartpump 3.0 Rechargeable Double Electric Breast Pump

Lansinoh Smartpump 3.0 Rechargeable Double Electric Breast Pump /Smartpump 3.0 oplaadbare dubbele elektrische borstkolf / Tire-lait électrique double rechargeable Smartpump 3.0

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd. Sti.
Manufacturer SRN: TR-MF-000021021
UDI-DI: 05060420233872
Basic UDI-DI: 506042023TF-800-11MC
Reference: 53368
EMDN: Z12080303
EMDN description: BREAST PUMPS
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 08:45

Manufacturer products View details

Lansinoh Wearable Pumping Cup

Lansinoh Wearable Pumping Cup / Draagbare Kolfcups / Set D'expression Mains Libres

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd. Sti.
Manufacturer SRN: TR-MF-000021021
UDI-DI: 05060420235203
Basic UDI-DI: 506042023TF-800-12ME
Reference: 53656
EMDN: Z12080399
EMDN description: VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 08:45

Manufacturer products View details

LifeStart™ (230V)

LifeStart™

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: SLE Ltd
Manufacturer SRN: GB-MF-000004155
UDI-DI: 05051380010436
Basic UDI-DI: 5051380LIFESTART95
Reference: LSU003US
EMDN: Z12080405
EMDN description: NEONATAL RESUSCITATION BEDS
First on market country: Sweden
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:02

Manufacturer products Authorised representative products Authorised representative actors View details

DELIVERY BED DG-880

Class IMDR 2017/745On the market

Manufacturer: Takara Belmont Corporation
Manufacturer SRN: JP-MF-000012052
UDI-DI: 04952195454648
Basic UDI-DI: 4952195ATDGB
Reference: AT-880VDC5EU
EMDN: Z12080399
EMDN description: VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Takara Company Europe GmbH
Last updated: 31.07.2026 07:27

Manufacturer products Authorised representative products Authorised representative actors View details

MIRI® M Chamber

MIRI® M-C

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Esco Medical Technologies, UAB
Manufacturer SRN: LT-MF-000010902
UDI-DI: 04779041940809
Basic UDI-DI: 477904194MIRIMFAMFA
Reference: MIRI® M Chamber
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Lithuania
Authorised representative: -
Last updated: 31.07.2026 07:04

Manufacturer products View details