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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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Obstetrics and gynaecology instruments
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Neonatology instruments
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Paediatric phototherapy equipment
Paediatric phototherapy equipment
Z12080401
143 devices
Bilicompact® Led
Weyer GmbH
·
,
Germany
Class IIa
CE/MDD
Infant Phototherapy Units
Zhengzhou Dison Instrument and Meter Co., Ltd.
·
,
China
Class IIa
CE/MDR
Giraffe Blue Spot PT Lite
Datex-Ohmeda Inc.
·
,
United States
Class IIa
CE/MDR
neoBLUE blanket Small pad
Natus Medical Denmark ApS
·
,
Denmark
Class IIa
CE/MDR
GUDID
on market
Sapphire
nice Neotech Medical Systems Pvt. Ltd.,
·
,
India
Class IIa
CE/MDR
Jw-PU1000
JW Pharmaceutical Corporation
·
,
South Korea
Class IIa
CE/MDD
Neonate Bilirubin Phototherapy Equipment
Ningbo David Medical Device Co., Ltd.
·
,
China
Class IIa
CE/MDD
bili-hut nest and mattress consumables
Little Sparrows Technologies, Inc.
·
,
United States
Class I
CE/MDR
GUDID
on market
Neonatal Phototherapy Bed
Shenzhen Comen Medical Instruments Co., LTD.
·
,
China
Class IIa
CE/MDR
neoBLUE blanket Large Disposable Mattress Cover (package of 50)
Natus Medical Denmark ApS
·
,
Denmark
Class IIa
CE/MDR
GUDID
on market
Careblue
Tende Elektronik Yazılım Mühendislik İletişim Makine Sanayi Ve Ticaret Ltd. Şti.
·
,
Türkiye
Class IIb
CE/MDD
BiliSwaddler
conceptnatal
·
,
Germany
Class I
CE/MDR
neoBLUE blanket LED Phototherapy System Light Box with power supply
Natus Medical Denmark ApS
·
,
Denmark
Class IIa
FDA 510(k)
×2
K182178
Active
Cleared 13 Dec 2018
CE/MDR
+1
authorizations
bili-hut nest and mattress consumables
Little Sparrows Technologies, Inc.
·
,
United States
Class I
CE/MDR
GUDID
on market
BiliWrap
Gerium Medical Ltd.
·
,
Israel
Class IIa
FDA 510(k)
K243372
Active
Cleared 29 May 2025
CE/MDR
Blue Angel LED Phototherapy Device
Ertunç Özcan
·
,
Türkiye
Class IIa
CE/MDD
Infant Phototherapy Equipment
Shenzhen Comen Medical Instruments Co., LTD.
·
,
China
Class IIa
CE/MDR
Giraffe Blue Spot PT Lite
Datex-Ohmeda Inc.
·
,
United States
Class IIa
CE/MDR
bili-hut
Little Sparrows Technologies, Inc.
·
,
United States
Class IIa
CE/MDR
44911230411
Active
Valid to Mar 2030
GUDID
on market
Giraffe Blue Spot PT Lite
Datex-Ohmeda Inc.
·
,
United States
Class IIa
CE/MDR
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