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Plastalume 10331

by Brownmed, Inc.

Ref 10331Model Size 1

Plastalume 10331 is a Class I device made by Brownmed, Inc., registered in EUDAMED on 28 May 2026 (Basic UDI-DI 082161PDWTGD) and listed in FDA GUDID since 14 Aug 2020 (UDI-DI 00821611033184), 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 Number082161PDWTGD Basic UDI-DI 00821611033184UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821611033184 UDI-DI Date14 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 082161PDWTGD registered 28 May 2026 Active
  • FDA GUDID UDI-DI 00821611033184 listed 14 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00821611033184
  2. Registered EUDAMED 082161PDWTGD

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  • Withdrawn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
DIGIwrap™ TOO EUDAMED
Plastalume GUDID
Generic name
Hand/finger splint, reusable
Device name
PLASTALUME® DIGIwrap™ TOO
Model / reference
10331, Size 1
Primary DI / UDI-DI
00821611033184 EUDAMED
00082161103318 GUDID
Basic UDI-DI
082161PDWTGD
FDA product code
ILH
EMDN code
M03050299 Bandages and splints - other
GMDN term
Hand/finger splint, reusable
Device class
Class I
Regulation number
890.3475
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
00821611033184
GUDID
00082161103318

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821611033184; FDA GUDID lists 00082161103318), so their flags are not compared.

Related devices

Category: Hand/finger splint, reusable

Similar devices in this category

Other devices filed under BANDAGES AND SPLINTS - OTHER.

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)