Enspire

The enspire 300 Series Automated Endoscope Reprocessor, 208V, Non-vented, Wall Drain is designed to effectively test, clean, high level disinfect, rinse and air purge up to two…

Registry build 21.09.26

The enspire 300 Series Automated Endoscope Reprocessor, 208V, Non-vented, Wall Drain is designed to effectively test, clean, high level disinfect, rinse and air purge up to two heat-sensitive, immersible, reusable, semi-critical devices including, but not limited to, GI flexible endoscopes such as bronchoscopes, gastroscopes, and duodenoscopes; or up to six non-channeled naso-endoscopes.

1manufacturer
8catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MED
Manufacturer City Province Registered as Device types
Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 5

Record

Regulatory record for enspire
Listed by Corporation Steris Canada
FDA product code MED
Device type Sterilant, Medical Devices
Device class Class 2
Regulation 21 CFR 880.6885
510(k) K230560
Record published 2024-04-17
Record revised 2024-08-26 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for enspire
Catalogue number Size Status
enspire 300 Series In distribution
enspire 300 Series In distribution
enspire 300 Series In distribution
enspire 300 Series In distribution
enspire 300 Series In distribution
enspire 300 Series In distribution
enspire 300 Series In distribution
enspire 300 Series In distribution

Same Product Code

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Product Sold by Catalogue numbers
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Showing 12 of 96. All products under Sterilant, Medical Devices

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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