Specula Accessories

Who Makes This Device Type in China?

3 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Zhejiang. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
Nanhai YI XIN Plastic Tableware Manufacturing Co Ltd Guangdong

How Is FXG Classified?

Specula Accessories is FDA product code FXG, Class 1, 21 CFR 878.1800.

How Does It Reach the US Market?

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 1 recall under this product code since 2022. None was by a company in China. The root cause the FDA records most often is Device Design (1).

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

Specula Accessories

Reusable Ear Funnels Ø 4.0 Mm, 10 Pcs.

Catalogue number 01.72213.001, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Specula Accessories. 3 manufacturers in China are registered for this product code.

Specula Accessories

N9 Speculum

ENT ear speculum for Nonagon N9 device

Specula Accessories

Avalign

Shea Speculum Holder

Specula Accessories

Ear Funnel, Small, Grey, Ø 2.5 Mm, 10 X 100 Pcs. In Carton

Catalogue number 01.71212.002, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Specula Accessories. 3 manufacturers in China are registered for this product code.

Specula Accessories

Ear Funnel, Black, Small Ø 2.5 Mm, in Units of 100 Pcs.

Catalogue number 01.71112.001, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Specula Accessories. 3 manufacturers in China are registered for this product code.

Specula Accessories

Ear Funnel, Grey, Large, Ø 4,0 Mm, PU = 1000 Pcs.

Catalogue number 01.71221.002, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Specula Accessories. 3 manufacturers in China are registered for this product code.

Specula Accessories

Symmetry Shea

Symmetry® Speculum, Shea Ear Holder, 11 3/4 in, 298 mm

Specula Accessories

Novo Surgical Inc.

shea ear speculum holder, 11 3/4" (30.0 cm)

Specula Accessories

MicroFrance®

LOANER Universal Flexible Arm Speculum Holder Kit

Specula Accessories

Ear Funnel, Large, Grey, Ø 4.0 Mm, 10 X 100 Pcs. In Carton

Catalogue number 01.71222.002, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Specula Accessories. 3 manufacturers in China are registered for this product code.

Specula Accessories

Ocular Exam Neonatal Speculum

Disposable Neonatal Speculum

Specula Accessories

Aesculap

Shea Speculum Holder 299MM

Specula Accessories

BR Surgical, LLC

Bolt and screw, upper, replacement for standard GRAVES and PEDERSON vaginal speculum

Specula Accessories

Millennium

Shea Speculum Holder

Specula Accessories

Integra®

Integra® Table Straight Bracket Blade

Specula Accessories

Neonatal Ocular Exam Kit 2-Pack

Neonatal Speculum & Depressor 2-pack

Specula Accessories

Pilling

Catalogue number IPN021249, listed by Teleflex Medical LLC, United States, under Specula Accessories. 3 manufacturers in China are registered for this product code.

Specula Accessories

Neotech Ocular Exam Kit

The Neotech Ocular Exam Kit is intended to assist in ocular examinations.

Specula Accessories

Ear Funnel, Black, Large Ø 4.0 Mm, in Units of 100 Pcs.

Catalogue number 01.71122.001, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Specula Accessories. 3 manufacturers in China are registered for this product code.

Specula Accessories

Ear Funnel, Grey, Large Ø 4.0 Mm, 10×100 Pcs. In Polybag

Catalogue number 01.71222.001, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Specula Accessories. 3 manufacturers in China are registered for this product code.

Specula Accessories

Ear Funnel, Grey, Small Ø 2.5 Mm, 10 X 100 Pcs. In Polybag

Catalogue number 01.71212.001, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Specula Accessories. 3 manufacturers in China are registered for this product code.

Specula Accessories

Realstar Surgical Instruments

SMOKE EVACUATOR TUBING FOR LEEP AND LASER VAGINAL SPECULA Specula Accessory

Specula Accessories

Ocular Exam Standard Speculum

Disposable Standard Speculum

Specula Accessories

Ear Funnel, Grey, Small, Ø 2,5 Mm, PU = 1000 Pcs.

Catalogue number 01.71211.002, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Specula Accessories. 3 manufacturers in China are registered for this product code.

Specula Accessories

Ocular Exam Depressor

Disposable Depressor

Specula Accessories

Ambler Surgical

Shea ear speculum holder, 11 3/4''

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