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Dempsey Splint 20-10603

by Invotec International, Inc.

Part of a family of 28 devices: see the family page

Ref 20-10603Model Internal Nasal Splint

Dempsey Splint 20-10603 is a Class I device made by Invotec International, Inc., registered in EUDAMED on 26 May 2026 (Basic UDI-DI 081850102IntNasalSplintHX) and listed in FDA GUDID since 6 Dec 2022 (UDI-DI 00818501020782), 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 Number081850102IntNasalSplintHX Basic UDI-DI 00818501020782UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818501020782 UDI-DI Date6 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081850102IntNasalSplintHX registered 26 May 2026 Active
  • FDA GUDID UDI-DI 00818501020782 listed 6 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00818501020782
  2. Registered EUDAMED 081850102IntNasalSplintHX

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  • Withdrawn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
Dempsey Internal Nasal Splint EUDAMED
Dempsey Splint GUDID
Generic name
Intranasal splint, non-biodegradable
Device name
Internal Nasal Splint
Model / Ref / Catalog
20-10603, Internal Nasal Splint
Primary DI / UDI-DI
00818501020782
Basic UDI-DI
081850102IntNasalSplintHX
FDA product code
LYA
EMDN code
Q0399 ENT devices - other
GMDN term
Intranasal splint, non-biodegradable
Device class
Class I
Regulation number
874.4780
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intranasal splint, non-biodegradable

Similar devices in this category

Other devices filed under ENT DEVICES - OTHER.

Other devices from Invotec International, Inc.

See all devices from Invotec International, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)