Injector, Pen

Which Manufacturers in China Make This?

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

Promisemed Hangzhou Meditech Co., Ltd. Zhejiang, contract manufacturer
Sanmina Jiangsu, contract manufacturer

What Is It?

A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.

What Is FDA Product Code NSC?

Injector, Pen is FDA product code NSC, Class 2, 21 CFR 880.5860.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

AutoTouch Reusable Autoinjector

AutoTouch reusable autoinjector for use with Enbrel Mini (etanercept) single-dose prefilled cartridge

Genotropin Pen® 12

A non-sterile, reusable pen injector designed to be used by a patient to subcutaneously inject human growth hormone using a replaceable Two-Chamber Cartridge (TCC) containing Genotropin…

Follistim PEN Starter KIT SAM

Catalogue number 1044943, listed by Organon LLC, United States, under Injector, Pen. 2 manufacturers in China are registered for this product code.

Omnitrope® Pen 5

The Omnitrope Pen 5 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It…

Follistim PEN Starter KIT USA

Catalogue number 1022692, listed by Merck, Sharp & Dohme, United States, under Injector, Pen. 2 manufacturers in China are registered for this product code.

Genotropin Pen® 5

A non-sterile, reusable pen injector designed to be used by a patient to subcutaneously inject human growth hormone using a replaceable Two-Chamber Cartridge (TCC) containing Genotropin…

Omnitrope Pen 10

The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It…

Follistim PEN Starter KIT SAM USA

Catalogue number 1746811, listed by Merck, Sharp & Dohme, United States, under Injector, Pen. 2 manufacturers in China are registered for this product code.

AutoTouch Connect Reusable Autoinjector

AutoTouch Connect reusable autoinjector with optional Bluetooth wireless feature for use with Enbrel Mini (etanercept) single-dose prefilled cartridge

Follistim PEN Starter KIT

The FOLLISTIM Pen Starter Kit is an injector accessory for use with the FOLLISTIM AQ Cartridge. The reusable pen accepts the specified cartridge and provides a mechanical interface for…

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