Steris Amsco Millennium Steam Sterilizer

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls on record, checked 22 Oct 2026.

Trade Name

Amsco

Device Name

AMSCO 600 Steam Sterilizer

Model / Reference

AMSCO 600 Steam Sterilizer, EF3302453001010003, EF3201252021000003, EF3201252021020003

Primary DI / UDI-DI

00724995226275, 00724995230784, 00724995230821

Basic UDI-DI

0724995CMMYAMSCO600SSW7

510(k) Number

K000077 ↗

FDA Product Code

FLE

EMDN Code

Z12011304 Autoclaves with a chamber larger than or equal to 1 standard sterilisation unit

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 880.6880

Market of Registration

Ireland

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Alyon

  Class I

  CE/MDR

• Amsco

  Class IIa

  CE/MDR

• Prolystica

  Class I

  CE/MDR

• Revital-Ox

  Class I

  CE/MDR

• AMSCO 300 Accessory

  Class I

  CE/MDR

• Steris

  Class I

  CE/MDR

See all devices from Steris Corporation →

• What types of items can be sterilized using the Steris Amsko Millennium Steam Sterilizer, and how does it ensure compliance with healthcare standards?

  The Steris Amsko Millennium Steam Sterilizer is designed for high-temperature sterilization of medical and surgical instruments, devices, and supplies using saturated steam under pressure. It achieves microbial decontamination that meets stringent sterilization standards required in healthcare environments, ensuring compliance with industry regulations for reprocessing reusable medical items.

• Is the Steris Amsko Millennium Steam Sterilizer intended for single-use or reusable applications, and what does this mean for maintenance?

  The Steris Amsko Millennium Steam Sterilizer is a reusable unit, meaning it is not meant for single-use. Since it operates as a non-sterile device, proper installation, maintenance, and adherence to manufacturer guidelines are essential to ensure optimal performance, safety, and continued compliance with sterilization protocols in healthcare settings.

• What regulatory pathways has the Steris Amsko Millennium Steam Sterilizer followed, and which healthcare settings is it authorized for?

  The device has undergone FDA 510(k) clearance and EU MDR authorization, classifying it under Class II (Special) for regulatory purposes. It is authorized for use in general hospital settings, as indicated by its FEI numbers and registration numbers, which cover multiple healthcare facilities. These pathways ensure its compliance with both U.S. and European regulatory standards.

• Does the Steris Amsko Millennium Steam Sterilizer require any special storage conditions, and how should it be handled before use?

  While the provided data does not specify exact storage conditions, the manufacturer’s guidelines must be followed to ensure optimal performance and safety. Since it is a reusable, non-sterile unit, proper installation, maintenance, and adherence to operational protocols are critical. Storage should ideally be in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage or contamination.