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Parkell®

by Parkell Inc. 31 variants

Ref S275

Parkell® (S275) is a device classified as Class I in the EU and Class II in the US made by Parkell, Inc., registered in EUDAMED on 18 Nov 2022 (Basic UDI-DI 081000052MIXINGTIP2JX) and listed in FDA GUDID since 21 Sep 2018 (UDI-DI 10810000526847), active as of 24 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081000052MIXINGTIP2JX Basic UDI-DI 10810000526847UDI-DIDate18 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number10810000526847 UDI-DI Date21 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081000052MIXINGTIP2JX registered 18 Nov 2022 Active
  • FDA GUDID UDI-DI 10810000526847 listed 21 Sep 2018 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 10810000526847
  2. Registered EUDAMED 081000052MIXINGTIP2JX

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  • Withdrawn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
Parkell® EUDAMED
SEcure® GUDID
Generic name
Dental material mixing nozzle
Device name
Mixing Tip 2
Model / Ref / Catalog
S275
Primary DI / UDI-DI
10810000526847
Basic UDI-DI
081000052MIXINGTIP2JX
Unit of use DI
00810000526840
FDA product code
EMA
EMDN code
Q019006 Dental material application tips and brushes, single-use
GMDN term
Dental material mixing nozzle
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3275
EU registration type
Standard device
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

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Related devices

Category: Dental material injection cannula, single-use

Similar devices in this category

Other devices filed under DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE.

Other devices from Parkell, Inc.

See all devices from Parkell, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)