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Stoma® 3323.16

by Storz am Mark GmbH

Ref 3323.16Model 38759 - Dental suction system cannula, reusable (037)

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

CE MDR

Valid until

11 Apr 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++ESAM03793 Basic UDI-DI +ESAM3323161UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+ESAM3323161 UDI-DI Date27 Aug 2020ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000330398 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    25 Sep 2026
    Expires
    11 Apr 2029
    Reason
    Add device or group

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  • Withdrawn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
Absaugrohr mit Pelotte, Ø11mm, 16cm EUDAMED
Stoma® GUDID
Generic Name
Dental suction system cannula, reusable
Model / Ref / Catalog
3323.16, 38759 - Dental suction system cannula, reusable (037)
Primary DI / UDI-DI
+ESAM3323161 EUDAMED
ESAM3323161 GUDID
Basic UDI-DI
++ESAM03793
FDA Product Code
GEA
EMDN Code
A0699 Drainage and fluid collection devices - other
GMDN Term
Dental suction system cannula, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+ESAM3323161
GUDID
ESAM3323161
Device ClassEUDAMED
Class IIa
GUDID
Class I

Other devices from Storz am Mark GmbH

See all devices from Storz am Mark GmbH →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No