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Sterile Shield LAF-02

by Toul Meditech AB

Ref LAF-02

Sterile Shield LAF-02 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 735010164LAFCU) with CE/MDR certificate 28620133939 valid until 29 Oct 2027 and listed in FDA GUDID since 13 Feb 2019 (UDI-DI 07350101640012), active as of 23 Oct 2026.

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

CE MDR

Valid until

29 Oct 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735010164LAFCU Basic UDI-DI 07350101640012UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350101640012 UDI-DI Date13 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 735010164LAFCU registered 26 May 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07350101640012 listed 13 Feb 2019 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

4 dated events

  1. Listed FDA GUDID 07350101640012
  2. Certificate issued EUDAMED 28620133939
  3. Registered EUDAMED 735010164LAFCU
  4. Certificate expires EUDAMED 28620133939

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Sterile Shields EUDAMED
Sterile Shield GUDID
Generic name
Surgical dressing/drape kit, single-use
Model / reference
LAF-02
Primary DI / UDI-DI
07350101640012 EUDAMED
07350101640029 GUDID
Basic UDI-DI
735010164LAFCU
Direct marketing DI
07350101640012
FDA product code
ORC
EMDN code
T0210 Non-surgical drapes
GMDN term
Surgical dressing/drape kit, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.5070
EU registration type
Standard device
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
07350101640012
GUDID
07350101640029
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 07350101640012; FDA GUDID lists 07350101640029), so their flags are not compared. 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 dressing/drape kit, single-use

Similar devices in this category

Other devices filed under NON-SURGICAL DRAPES.

Other devices from Toul Meditech AB

See all devices from Toul Meditech AB →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)