Skip to content

Shower Guard

by Freudenberg Medical LLC

Ref BE 6048

Shower Guard (BE 6048) is a Class I device made by Freudenberg Medical LLC, registered in EUDAMED on 1 Nov 2025 (Basic UDI-DI 08482530SHOWERGUARDBJ) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00813307012740), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08482530SHOWERGUARDBJ Basic UDI-DI 00813307012740UDI-DIDate1 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00813307012740 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08482530SHOWERGUARDBJ registered 1 Nov 2025 Active
  • FDA GUDID UDI-DI 00813307012740 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00813307012740
  2. Registered EUDAMED 08482530SHOWERGUARDBJ

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  • Withdrawn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
Shower Guard EUDAMED
InHealth Technologies; Blom-Singer GUDID
Generic name
Removable ambulatory appliance skin-adherent patch
Device name
Showerguard
Model / reference
BE 6048
Primary DI / UDI-DI
00813307012740
Basic UDI-DI
08482530SHOWERGUARDBJ
FDA product code
KGX, BYD, EWL
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Removable ambulatory appliance skin-adherent patch
Device class
Class I
Regulation number
880.5240, 868.5375, 874.3730
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000023823
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Pulmonary function analysis system, adult

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from Freudenberg Medical LLC

See all devices from Freudenberg Medical LLC →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)