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Irrigation Tube OSG03499ST35

by Promepla

Part of a family of 26 devices: see the family page

Ref C823752

Irrigation Tube OSG03499ST35 (C823752) is a device classified as Class IIa in the EU and Class I in the US made by Promepla, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 037005129DEN7Y) and listed in FDA GUDID since 24 Oct 2024 (UDI-DI 03700512905073), 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 Number037005129DEN7Y Basic UDI-DI 03700512905073UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700512905073 UDI-DI Date24 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 037005129DEN7Y registered 19 May 2026 Active
  • FDA GUDID UDI-DI 03700512905073 listed 24 Oct 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700512905073
  2. Registered EUDAMED 037005129DEN7Y

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  • Withdrawn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
Irrigation Tube
Generic name
Surgical irrigation/aspiration tubing set
Device name
Dental Tubing lines
Model / Ref / Catalog
C823752, OSG03499ST35
Primary DI / UDI-DI
03700512905073
Basic UDI-DI
037005129DEN7Y
FDA product code
GBX
EMDN code
Q0199 Odontology devices - other
GMDN term
Surgical irrigation/aspiration tubing set
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4200
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
C823752
GUDID
OSG03499ST35
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: Surgical irrigation/aspiration tubing set

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from Promepla

See all devices from Promepla →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)