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Seal-Tight 20204

by Brownmed, Inc.

Ref 20204Model Pediatric Medium Leg

Seal-Tight 20204 is a Class I device made by Brownmed, Inc., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 082161STOPMDLDE) and listed in FDA GUDID since 11 Aug 2020 (UDI-DI 00821612020428), 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 Number082161STOPMDLDE Basic UDI-DI 00821612020428UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821612020428 UDI-DI Date11 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 082161STOPMDLDE registered 29 May 2026 Active
  • FDA GUDID UDI-DI 00821612020428 listed 11 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00821612020428
  2. Registered EUDAMED 082161STOPMDLDE

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  • Withdrawn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
Original CAST PROTECTORS EUDAMED
Seal-Tight GUDID
Generic name
Cast/bandage waterproof bathing cover, reusable
Device name
SEAL-TIGHT® Original CAST PROTECTORS Pediatric Medium Leg
Model / reference
20204, Pediatric Medium Leg
Primary DI / UDI-DI
00821612020428 EUDAMED
00082161202042 GUDID
Basic UDI-DI
082161STOPMDLDE
FDA product code
KIA
EMDN code
M03030299 Protection systems - other
GMDN term
Cast/bandage waterproof bathing cover, reusable
Device class
Class I
Regulation number
880.6185
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821612020428
GUDID
00082161202042

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821612020428; FDA GUDID lists 00082161202042), so their flags are not compared.

Related devices

Category: Cast/bandage waterproof bathing cover, reusable

Similar devices in this category

Other devices filed under PROTECTION SYSTEMS.

Other devices from Brownmed, Inc.

See all devices from Brownmed, Inc. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)