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Parkell®

by Parkell Inc. 3 variants

Ref S545Model S535

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081000052MIXINGTIP5K5 Basic UDI-DI 10810000528308UDI-DIDate29 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Mixing Tip 5
Model / Reference
S535, S545
Primary DI / UDI-DI
10810000528308
Basic UDI-DI
081000052MIXINGTIP5K5
Unit of Use DI
00810000528301
EMDN Code
Q019006 Dental material application tips and brushes, single-use
Device Class
Class I
EU market of registration
Germany

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

Other properties (13)

  • 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