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SteriStay

FDA UDI

Class II (US FDA UDI)

by Toul Meditech AB

Identity

Trade Name
SteriStay FDA UDI
Generic Name
Surgical laminar airflow unit FDA UDI
Device Name
SteriStay is a mobile instrument table intended for use in the operating environment that produces a directed, non-turbulent flow of air over sterile instruments and goods. The airflow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms. FDA UDI
Model / Reference
B2 FDA UDI
Description
SteriStay is a mobile instrument table intended for use in the operating environment that produces a directed, non-turbulent flow of air over sterile instruments and goods. The airflow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms. FDA UDI

Identifiers

Primary DI / UDI-DI
07350101640043 FDA UDI
FDA Product Code
ORC FDA UDI
GMDN Term
Surgical laminar airflow unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical laminar airflow unit

SteriStay by Toul Meditech AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical laminar airflow unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Toul Meditech AB

Sources (1)

  • FDA UDI a20980a0-9146-4f87-a06e-e582060ba293 33 fields · synced May 30, 2026