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Sheathes 20040

by Sheathing Technologies, Inc.

Part of a family of 47 devices: see the family page

Ref 20040

Sheathes 20040 is a device classified as Class I in the EU and Class II in the US made by Sheathing Technologies, Inc., registered in EUDAMED on 8 Jun 2026 (Basic UDI-DI 08424181C1PSES), cleared under FDA 510(k) K990175 on 21 Apr 1999 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00842418100244), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K990175

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08424181C1PSES Basic UDI-DI 00842418100244UDI-DIDate8 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842418100244 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK990175 Date21 Apr 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08424181C1PSES registered 8 Jun 2026 Active
  • FDA 510(k) K990175 decided 21 Apr 1999 Active
  • FDA GUDID UDI-DI 00842418100244 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K990175
  2. Listed FDA GUDID 00842418100244
  3. Registered EUDAMED 08424181C1PSES

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Ultrashcallsondenabdeckung EUDAMED
Sheathes GUDID
Generic name
Body-orifice ultrasound imaging transducer cover, basic
Model / reference
20040
Primary DI / UDI-DI
00842418100244 EUDAMED
10842418100241 GUDID
Basic UDI-DI
08424181C1PSES
510(k) Number
FDA product code
ITX
EMDN code
T030199 Covers, instruments and equipment - other
GMDN term
Body-orifice ultrasound imaging transducer cover, basic
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00842418100244
GUDID
10842418100241
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00842418100244; FDA GUDID lists 10842418100241), 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

Cleared under the same submission (K990175)

and 8 more cleared under K990175

Similar devices in this category

Other devices filed under COVERS, INSTRUMENTS AND EQUIPMENT - OTHER.

Other devices from Sheathing Technologies, Inc.

See all devices from Sheathing Technologies, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)