Skip to content

TIDIShield 5412

by TIDI Products, LLC.

Part of a family of 19 devices: see the family page

Ref 5412

TIDIShield 5412 is a device classified as Class I in the EU and Class II in the US made by TIDI Products, LLC., registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI 0618125TF0022A77) and listed in FDA GUDID since 29 Sep 2022 (UDI-DI 00618125140060), active as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0618125TF0022A77 Basic UDI-DI 00618125140060UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00618125140060 UDI-DI Date29 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0618125TF0022A77 registered 2 Oct 2026 Active
  • FDA GUDID UDI-DI 00618125140060 listed 29 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00618125140060
  2. Registered EUDAMED 0618125TF0022A77

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  • Withdrawn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
Image Intensifier/X-Ray Tube Cover 36'' x 36'' (91 x 91 cm) with Rubber Band EUDAMED
TIDIShield GUDID
Generic name
Medical equipment/instrument drape, single-use
Device name
General sterile medical barriers
Model / Ref / Catalog
5412
Primary DI / UDI-DI
00618125140060
Basic UDI-DI
0618125TF0022A77
FDA product code
PUI
EMDN code
T030102 Cover sheaths, instruments and equipments
GMDN term
Medical equipment/instrument drape, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4370
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Medical equipment/instrument drape, single-use

Similar devices in this category

Other devices filed under COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS.

Other devices from TIDI Products, LLC.

See all devices from TIDI Products, LLC. →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)