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Absorbent Tipped Applicators, Non-Sterile

by Puritan Medical Products Company 41 variants

Ref 3317-U PRT

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10609576331111 UDI-DI Date20 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0609576ATANSU9 Basic UDI-DI 10609576331111UDI-DIDate8 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Puritan® PurFlock Ultra®
Generic Name
General-purpose absorbent tip applicator/swab, single-use
Device Name
Absorbent Tipped Applicators, Non-Sterile
Model / Ref / Catalog
3317-U PRT
Primary DI / UDI-DI
10609576331111
Basic UDI-DI
0609576ATANSU9
FDA Product Code
KXF
EMDN Code
A1101 Sample collection neutral swabs
GMDN Term
General-purpose absorbent tip applicator/swab, single-use
Device Class
Class I
Regulation Number
880.6025
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000007051
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Puritan Medical Products Company LLC

See all devices from Puritan Medical Products Company LLC →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No