Loupe, Diagnostic/Surgical

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Guangxi and Jiangsu, and 5 other provinces: 15 hold an FDA registration. 2 are contract manufacturers.

Alltion (Guangxi) Instrument Co., Ltd. Guangxi
Bothwin (Beijing) Medical Technology Co., Ltd. Beijing
Changzhou Sifary Medical Technology Co., Ltd. Jiangsu
Foshan Cicada Dental Instrument Co., Ltd. Guangdong
Gavin Biotechnology Co., Ltd. Shanxi
Guangxi Ehall Medical Technology Co., Ltd. Guangxi
Guilin Yikeshi Medical Device Co Ltd Guangxi
Huizhou Videya Technology Co., Ltd. Guangdong
Nanchang Micare Medical Equipment Co., Ltd. Jiangxi
Nanjing Yanan Special Lighting Factory Jiangsu
Shanghai Lions Industrial Co., Ltd. Shanghai, contract manufacturer
Shenzhen Denco Medical Co., Ltd. Guangdong, contract manufacturer
Shenzhen Rogin Medical Co., Ltd. Guangdong, contract manufacturer
Shanghai Jolly Industrial Co., Ltd. Shanghai, contract manufacturer
Zhejiang Fude Medphotonic Co., Ltd. Zhejiang

What Is FDA Product Code FSP?

Loupe, Diagnostic/Surgical is FDA product code FSP, Class 1, 21 CFR 878.4800.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2012. None was by a company in China. The root causes the FDA records most often are Labeling design (2) and Finished device change control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Loupe, Diagnostic/Surgical

ErgoZoom™ Rx – Dragonfly™

Dragonfly™ Powered Loupe with ErgoZoom™ Prescription Oculars

Loupe, Diagnostic/Surgical

HDL™ 5.5 Rx – XV1™

XV1™ loupe with HDL™ 5.5 prescription oculars

Loupe, Diagnostic/Surgical

HDL™ 3.5 Rx – XV1™

XV1™ loupe with HDL™ 3.5 prescription oculars

Loupe, Diagnostic/Surgical

OmniOptic™ Ocular Pair – HDL™ 3.5 Rx

OmniOptic™ Ocular Pair - HDL™ 3.5, prescription

Loupe, Diagnostic/Surgical

HDL™ 2.5 Macro Plano – XV1™

XV1™ loupe with HDL™ 2.5 Macro plano oculars

Loupe, Diagnostic/Surgical

Orascoptic – HDL 2.5 Micro Rx

Catalogue number HDL 2.5 Micro Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

OmniOptic™ Rx – Dragonfly™

Dragonfly™ powered loupe with OmniOptic™ prescription oculars

Loupe, Diagnostic/Surgical

Orascoptic – Dragonfly HDL 5.5 Rx

Catalogue number Dragonfly HDL 5.5 Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Orascoptic – HDL 3.0 Rx

Catalogue number HDL 3.0 Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Orascoptic – HDL Ergo 3.5

Catalogue number HDL Ergo 3.5, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

EyeZoom™ Mini Rx – Dragonfly™

Dragonfly™ powered loupe with EyeZoom™ Mini prescription oculars

Loupe, Diagnostic/Surgical

Orascoptic – Dragonfly EyeZoom Rx

Catalogue number Dragonfly EyeZoom Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Universal Clip

Universal Clip High Resolution/High Resolution Prismatic Loupe

Loupe, Diagnostic/Surgical

Orascoptic – EyeZoom Mini Rx

Catalogue number EyeZoom Mini Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

ErgoZoom™ Plano

Loupe with ErgoZoom™ Plano Oculars

Loupe, Diagnostic/Surgical

XV1™ – Headlight Only – Rx

XV1™ frame with no oculars (headlight only) and prescription lenses

Loupe, Diagnostic/Surgical

Cicada

Dental Head Loupes

Loupe, Diagnostic/Surgical

TTL Easy Size 2.5x Loupes Black

Catalogue number 7131117 BLA, listed by Practicon, Inc., United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

HDL Ergo 5.0 Rx

Catalogue number HDL Ergo 5.0 Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

OmniOptic™ Plano – XV1™

XV1™ loupe with OmniOptic™ plano oculars

Loupe, Diagnostic/Surgical

OmniOptic™ Ocular Pair – HDL™ 4.5 Rx

OmniOptic™ Ocular Pair - HDL™ 4.5, prescription

Loupe, Diagnostic/Surgical

Orascoptic – OmniOptic

Catalogue number OmniOptic, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Orascoptic – Dragonfly HDL 2.5 Micro Rx

Catalogue number Dragonfly HDL 2.5 Micro Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

HDL™ 3.5 Prism Rx – Dragonfly™

Dragonfly™ powered loupe with HDL™ 3.5 prescription oculars

Loupe, Diagnostic/Surgical

Orascoptic – HDL 2.5 Micro

Catalogue number HDL 2.5 Micro, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Orascoptic – HDL 2.5 Macro

Catalogue number HDL 2.5 Macro, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Orascoptic – Dragonfly EyeZoom Mini

Catalogue number Dragonfly EyeZoom Mini, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Orascoptic – HDL 3.0

Catalogue number HDL 3.0, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Dragonfly™ – Headlight Only – Plano

Dragonfly™ frame with no oculars (headlight only) and plano lenses

Loupe, Diagnostic/Surgical

Orascoptic – Dragonfly HDL 3.5 Rx

Catalogue number Dragonfly HDL 3.5 Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

HDL™ 4.5 Prism Plano – Dragonfly™

Dragonfly™ powered loupe with HDL™ 4.5 plano oculars

Loupe, Diagnostic/Surgical

Orascoptic – EyeZoom Max Rx – XV1

Loupe with prescription EyeZoom Max™ oculars on XV1™ frame

Loupe, Diagnostic/Surgical

Lithium-Polymer Replacement Battery

Lithium-Polymer Replacement Battery FOR Mpack Unplugged

Loupe, Diagnostic/Surgical

Sterilizable Levers

Sterilizable Levers FOR I-View High Resolution/High Resolution Prismatic Loupe

Loupe, Diagnostic/Surgical

HDL Ergo 5.0 Plano

Catalogue number HDL Ergo 5.0 Plano, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

HDL™ 4.5 Prism Rx – Dragonfly™

Dragonfly™ powered loupe with HDL™ 4.5 prescription oculars

Loupe, Diagnostic/Surgical

Orascoptic – Dragonfly HDL 3.5 Galilean Rx

Catalogue number Dragonfly HDL 3.5 Galilean Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

High Resolution Prismatic Loupe Optics

Catalogue number C-000.32.706, listed by Sontec Instruments, Inc., United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

EyeZoom™ Plano – XV1™

XV1™ loupe with EyeZoom™ plano oculars

Loupe, Diagnostic/Surgical

Orascoptic – Dragonfly EyeZoom Max Rx

Catalogue number Dragonfly EyeZoom Max Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Orascoptic – RDH Elite

Catalogue number RDH Elite, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

I-View Loupe Carrier

Catalogue number Z-763.01.000, listed by Sontec Instruments, Inc., United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

EyeZoom™ Mini Rx – XV1™

XV1™ loupe with EyeZoom™ Mini prescription oculars

Loupe, Diagnostic/Surgical

HDL™ 2.5 Micro Plano – XV1™

XV1™ loupe with HDL™ 2.5 Micro plano oculars

Loupe, Diagnostic/Surgical

Loupe Carrier Screw

Catalogue number Z-767.07.000, listed by Sontec Instruments, Inc., United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

TTL Easy Size 2.5x Loupes Red

Catalogue number 7131117 RED, listed by Practicon, Inc., United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

High Resolution Binocular Loupe

High Resolution Binocular Loupe I-View ON S-Frame

Loupe, Diagnostic/Surgical

EyeZoom™ Rx – Dragonfly™

Dragonfly™ powered loupe with EyeZoom™ prescription oculars

Loupe, Diagnostic/Surgical

TTL Easy Size 2.5x Loupes Silver

Catalogue number 7131117 SIL, listed by Practicon, Inc., United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

HDL™ 3.5 Plano – XV1™

XV1™ loupe with HDL™ 3.5 plano oculars

Loupe, Diagnostic/Surgical

Orascoptic – EyeZoom Rx

Catalogue number EyeZoom Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

EyeZoom™ Rx – XV1™

XV1™ loupe with EyeZoom™ prescription oculars

Loupe, Diagnostic/Surgical

Orascoptic – Dragonfly HDL 3.5 Galilean

Catalogue number Dragonfly HDL 3.5 Galilean, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Orascoptic – HDL 3.5 Galilean Rx

Catalogue number HDL 3.5 Galilean Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

OmniOptic™ Ocular Pair – HDL™ 5.5 Rx

OmniOptic™ Ocular Pair - HDL™ 5.5, prescription

Loupe, Diagnostic/Surgical

HDL™ 5.5 Prism Plano – Dragonfly™

Dragonfly™ powered loupe with HDL™ 5.5 plano oculars

Loupe, Diagnostic/Surgical

Digital Medical Scope

DS-10D is a digital hand-held dermatoscope used to record digital photographs and video of the human skin.

Loupe, Diagnostic/Surgical

EyeZoom™ Max Rx – Dragonfly™

Dragonfly™ powered loupe with EyeZoom™ Max prescription oculars

Loupe, Diagnostic/Surgical

Orascoptic – EyeZoom

Catalogue number EyeZoom, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Orascoptic – Dragonfly RDH Elite Rx

Catalogue number Dragonfly RDH Elite Rx, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

Orascoptic – Dragonfly HDL 5.5

Catalogue number Dragonfly HDL 5.5, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

HDL™ 3.0 Plano – Dragonfly™

Dragonfly™ powered loupe with HDL™ 3.0 plano oculars

Loupe, Diagnostic/Surgical

Orascoptic – Dragonfly RDH Ergo 3.0

Catalogue number Dragonfly RDH Ergo 3.0, listed by Metrex Research, United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Loupe, Diagnostic/Surgical

TTL Easy Size 3.0x Loupes Black

Catalogue number 7131118 BLA, listed by Practicon, Inc., United States, under Loupe, Diagnostic/Surgical. 15 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer