LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)

FDA 510(k)

FDA Class 1 ·Ophthalmic

F.O. Laryngoscope Set 2,5 V for adults/ pediatrics, Economy Macintosh/ Miller

Device

EU MDR · Eu Md Class 1 ·Kirchner & Wilhelm GmbH + Co KG·On the market

F.O. LED battery handle,short, 2.5 V, with high power LED

Device

EU MDR · Eu Md Class 1 ·Kirchner & Wilhelm GmbH + Co KG·On the market

2204C04210402

Certificate

MDD Annex II (excluding section 4)·ISO Med·HTCert (Health Technology Certification Ltd)·6 Basic UDI-DIs

EMS Neck Massager

FDA 510(k)

FDA Class 2 ·Physical Medicine

Follicle Stimulating Hormone（CLIA）、FSH Calibrators

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Klic10 Blood Collection Accessories Set F

Basic UDI-DI

EU MDR · Eu Md Class 2a ·1 device

ASO/CRP/RF Triple Control

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device

Anti-Streptolysin O (ASO) Calibrator

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

Anti-Streptolysin O (ASO) Calibrator

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

Anti-Streptolysin O (ASO) Calibrator

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

Aso Europe BV

Authorized representative

🇳🇱 Netherlands·2 Manufacturers·1 Device

AUTO KERATO/REFRACTOMETER

Basic UDI-DI

EU MDR · Eu Md Class 2a ·NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO.,LTD.·6 devices

ZZ BASE AS-OS-WMSM-L12 3.0 (White Metal Scanmarker L12 with Screw)

FDA UDI

ZIRKONZAHN SRL·D800ZBED0131L12·Compatible with ASTRA TECH Implant System Osseo...

ZZ BASE AS-OS-WMSM-L15 3.0 (White Metal Scanmarker L15 with Screw)

FDA UDI

ZIRKONZAHN SRL·D800ZBED0131L15·Compatible with ASTRA TECH Implant System Osseo...

Atlas ASO Latex Reagent, 5 ml/Vial, Individually Packed, 1 Vial /Box.

Device

EU IVDD · Eu Ivd General ·Atlas Medical GmbH·On the market

COMBILIGHT F.O.30 otoscope with charg. plug 240 V + accu 3.5 V

Device

EU MDR · Eu Md Class 1 ·Kirchner & Wilhelm GmbH + Co KG·On the market

EUROLIGHT F.O.30 otoscope with charg. plug 240 V + accu 3.5 V

Device

EU MDR · Eu Md Class 1 ·Kirchner & Wilhelm GmbH + Co KG·On the market

ASO Fast Test Kit (Immunofluorescence Assay)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Getein Biotech, Inc.·1 device

Atlas ASO Latex Kit , 100 Tests

Basic UDI-DI

EU IVDD · Eu Ivd General ·Atlas Medical GmbH·1 device