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Parkell®

by Parkell Inc. 31 variants

Ref S329

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081000052MIXINGTIPWR Basic UDI-DI 10810000526915UDI-DIDate17 Aug 2022RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number10810000526915 UDI-DI Date21 Sep 2018ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Parkell® EUDAMED
HyperFIL™ GUDID
Generic Name
Dental material injection cannula, single-use
Device Name
Mixing/Dispensing Tips
Model / Ref / Catalog
S329
Primary DI / UDI-DI
10810000526915
Basic UDI-DI
081000052MIXINGTIPWR
Unit of Use DI
00810000526918
FDA Product Code
EBF
EMDN Code
Q019006 Dental material application tips and brushes, single-use
GMDN Term
Dental material injection cannula, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3690
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000003761
Authorised representative
Directa AB SE-AR-000002492

Related devices

Category: Dental material injection cannula, single-use

Other devices from Parkell, Inc.

See all devices from Parkell, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No