Speculum, Vaginal, Nonmetal, Fiberoptic

Who Makes This Device Type in China?

One manufacturer in China holds an FDA registration for this device type, based in Zhejiang. All of them are contract manufacturers, able to build to a buyer’s own specification.

Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code HIC?

Speculum, Vaginal, Nonmetal, Fiberoptic is FDA product code HIC, Class 2, 21 CFR 884.4530.

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.

Speculum, Vaginal, Nonmetal, Fiberoptic

SpecuLume EZ

3 catalogue numbers from 7-67553, listed by Cyalume Technologies, Inc., under Speculum, Vaginal, Nonmetal, Fiberoptic. 1 manufacturer in China is registered for this product code.

Speculum, Vaginal, Nonmetal, Fiberoptic

Bioseal Inc.

Vaginal Speculum Clear X-Small, Light Source

Speculum, Vaginal, Nonmetal, Fiberoptic

Gynex SpecuLume EZ

Self Illuminated Vaginal Speculum (Medium, Screw Closure, Elevating)

Speculum, Vaginal, Nonmetal, Fiberoptic

SpecuLume

6 catalogue numbers from 7-51553, listed by Cyalume Technologies, Inc., under Speculum, Vaginal, Nonmetal, Fiberoptic. 1 manufacturer in China is registered for this product code.

Speculum, Vaginal, Nonmetal, Fiberoptic

Who Makes This Device Type in China?

What Is FDA Product Code HIC?

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

SpecuLume EZ

Bioseal Inc.

Gynex SpecuLume EZ

SpecuLume

Where China Actually Supplies