IB 4002 IceBand Face

FDA registration

IB Medical AB·1 product·🇸🇪 Sweden

Innoventa Medica ApS

Manufacturer

🇩🇰 Denmark·3 Basic UDI-DIs·8 Devices·Intertek Medical Notified Body AB, Intertek Medical Notified Body AB, and Intertek Medical Notified Body AB

Front Line Medical Technologies Inc.

Manufacturer

🇨🇦 Canada·2 Basic UDI-DIs·2 Devices·2 Importers·Intertek Medical Notified Body AB and Intertek Medical Notified Body AB

Breas Medical Limited

Manufacturer

9 Basic UDI-DIs·9 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Eyenuk, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·Intertek Medical Notified Body AB and INTERTEK SEMKO AB

Shenzhen Kentro Medical Electronics CO.,LTD.

Manufacturer

🇨🇳 China·5 Basic UDI-DIs·16 Devices·2 Importers·Intertek Medical Notified Body AB, INTERTEK SEMKO AB, and INTERTEK SEMKO AB

Amalgam Rx, Inc

Manufacturer

🇺🇸 United States·Intertek Medical Notified Body AB

SmileSonica Inc.

Manufacturer

🇨🇦 Canada·Intertek Medical Notified Body AB

Agfa HealthCare NV

Manufacturer

🇧🇪 Belgium·2 Basic UDI-DIs·2 Devices·Intertek Medical Notified Body AB

Sri Anusham Rubber Industries Private Limited

Manufacturer

🇮🇳 India·Intertek Medical Notified Body AB

Koios Medical Inc.

Manufacturer

🇺🇸 United States·Intertek Medical Notified Body AB

Mosaic Surgical Ltd

Manufacturer

29 Basic UDI-DIs·63 Devices·1 Importer·BSI Group The Netherlands B.V.

VagiVital Aktivgel

FDA registration

Peptonic Medical AB·1 product·🇸🇪 Sweden

Oximeter

FDA registration

3B Medical Inc·1 product·🇺🇸 United States

iOTM Mini Nasal Mask (Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2)

FDA registration

3B Medical Inc·1 product·🇺🇸 United States

Numa II Full Face Mask (F4) - (Device Modification) ((Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)

FDA registration

3B Medical Inc·1 product·🇺🇸 United States

Generator, oxygen, portable

FDA registration

3B Medical Inc·1 product·🇺🇸 United States

Luna G3 BPAP 25/30VT

FDA registration

3B Medical Inc·1 product·🇺🇸 United States

RESmart CPAP and Auto CPAP (3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP)

FDA registration

3B Medical Inc·1 product·🇺🇸 United States

iCodeConnect

FDA registration

3B Medical Inc·1 product·🇺🇸 United States