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SteriStay B2

by Toul Meditech AB

Ref 7350101640043Model SteriStay

SteriStay B2 is a device classified as Class I in the EU and Class II in the US made by Toul Meditech AB, registered in EUDAMED on 26 May 2026 (Basic UDI-DI 735010164SteristayM6) and listed in FDA GUDID since 5 Sep 2019 (UDI-DI 07350101640043), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735010164SteristayM6 Basic UDI-DI 07350101640043UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350101640043 UDI-DI Date5 Sep 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 735010164SteristayM6 registered 26 May 2026 Active
  • FDA GUDID UDI-DI 07350101640043 listed 5 Sep 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07350101640043
  2. Registered EUDAMED 735010164SteristayM6

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
SteriStay
Generic name
Surgical laminar airflow unit
Model / reference
SteriStay EUDAMED
7350101640043 EUDAMED
B2 GUDID
Primary DI / UDI-DI
07350101640043
Basic UDI-DI
735010164SteristayM6
Direct marketing DI
07350101640043
FDA product code
ORC
EMDN code
V0899 Medical support equipment - other
GMDN term
Surgical laminar airflow unit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.5070
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SteriStay
7350101640043
GUDID
B2
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical laminar airflow unit

Similar devices in this category

Other devices filed under MEDICAL SUPPORT EQUIPMENT - OTHER.

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Properties

  • Premarket exempt
  • Serial number
Other properties (23, all answered No)