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DryDent

by Directa AB

Ref 416069

DryDent (416069) is a Class I device made by Directa AB, registered in EUDAMED on 16 Jun 2025 (Basic UDI-DI 731023999520AQ) and listed in FDA GUDID since 6 Dec 2022 (UDI-DI 17310234160693), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number731023999520AQ Basic UDI-DI 17310234160693UDI-DIDate16 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number17310234160693 UDI-DI Date6 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 731023999520AQ registered 16 Jun 2025 Active
  • FDA GUDID UDI-DI 17310234160693 listed 6 Dec 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 17310234160693
  2. Registered EUDAMED 731023999520AQ

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  • Withdrawn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

Generic name
Saliva absorbent
Device name
Saliva absorbent
Model / Ref / Catalog
416069, Sublingual S
Primary DI / UDI-DI
17310234160693
Basic UDI-DI
731023999520AQ
Unit of use DI
17310231057804
FDA product code
KHR
EMDN code
Q019001 Saliva aspirators and saliva absorbents
GMDN term
Saliva absorbent
Device class
Class I
Regulation number
872.6050
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
416069
GUDID
Sublingual S

Manufacturer details

EUDAMED SRN
SE-MF-000002500

Similar devices in this category

Other devices filed under SALIVA ASPIRATORS AND SALIVA ABSORBENTS.

Other devices from Directa AB

See all devices from Directa AB →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)