N/A

FDA UDI

SALTER LABS·00607411930393·Luma Wrap, extra large

N/A

FDA UDI

SALTER LABS·00607411930386·Luma Wrap, medium

Swaddler for Phototherapy

FDA UDI

Bionix, LLC·00859911004276·Swaddler for PhotoTherapy: Preemie

BIONIX DEVELOPMENT CORPORATION

FDA UDI

M&H Medical Holdings, Inc.·08599110040133·Swaddler for PhotoTherapy, preemie

G-6-PDH DEFICIENT CONTROL (G-6-PDH CONTROL D)

FDA UDI

RANDOX LABORATORIES LIMITED·05055273204773·

G-6-PDH NORMAL CONTROL (G-6-PDH CONTROL N)

FDA UDI

RANDOX LABORATORIES LIMITED·05055273204780·

G-6-PDH CONTROL

Device

EU IVDR · Eu Ivd Class C ·Medicon Hellas SA·On the market·3 countries

G-6-PDH CALIBRATOR

Device

EU IVDR · Eu Ivd Class C ·Medicon Hellas SA·On the market·2 countries

PTH CONTROL LEVEL 1 (PTH CONTROL 1)

FDA registration

RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom

PTH CONTROL LEVEL 1 (PTH CONTROL 1)

FDA registration

RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom

LITTLE ANGELS SWADDLING BLANKET

FDA 510(k)

FDA Class 2 ·General Hospital

Luma Wrap

FDA 510(k)

FDA Class 2 ·General Hospital

G-6-PDH

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Medicon Hellas SA·6 devices

EKa(p)DH

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·2 devices

Blanket, Neonatal Phototherapy

FDA classification

FDA Class 2 ·Blanket, Neonatal Phototherapy

DDH Inc

Manufacturer

🇰🇷 South Korea

Adhe-Els SA.

Manufacturer

🇹🇳 Tunisia·167 Basic UDI-DIs·167 Devices·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

mdh sp. z o. o.

Manufacturer

🇵🇱 Poland·11 Basic UDI-DIs·21 Devices

PDC Restorer

FDA registration

PDC RESTORER, LLC·1 product·🇺🇸 United States

NDH MEDICAL, INC.

FDA registration

NDH MEDICAL, INC.·1 product·🇺🇸 United States