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DryShield BMD DS-SYS-002

by Solmetex, LLC

Ref DS-SYS-002

DryShield BMD DS-SYS-002 is a dental suction system (EU MDD Class IIa; FDA Class I; FDA product code DZN, Instruments, Dental Hand) made by Solmetex, LLC, registered in EUDAMED on 6 May 2026 (Basic UDI-DI B-00850045062224) and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 00850045062224), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-00850045062224 Basic UDI-DI 00850045062224UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850045062224 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00850045062224 registered 6 May 2026 Active
  • FDA GUDID UDI-DI 00850045062224 listed 7 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850045062224
  2. Registered EUDAMED B-00850045062224

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
DryShield
Generic name
Dental suction system
Device name
Dryshield Isolation System and Mouthpieces
Model / reference
DS-SYS-002 EUDAMED
BMD DS-SYS-002 GUDID
Primary DI / UDI-DI
00850045062224
Basic UDI-DI
B-00850045062224
FDA product code
DZN
EMDN code
Q019001 Saliva aspirators and saliva absorbents
GMDN term
Dental suction system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
DS-SYS-002
GUDID
BMD DS-SYS-002
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental suction system

Similar devices in this category

Other devices filed under SALIVA ASPIRATORS AND SALIVA ABSORBENTS.

Other devices from Solmetex, LLC

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Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)