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Pindex System Pindex Handsaw Kit

by Coltene/Whaledent Inc.

Ref PX200

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D661019KN Basic UDI-DI D661PX2000UDI-DIDate26 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD661PX2000 UDI-DI Date26 Feb 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Pindex System Pindex Handsaw Kit EUDAMED
Pindex GUDID
Generic Name
Dental laboratory power tool system
Device Name
Pindex Model and Die Fabrication System
Model / Reference
PX200
Primary DI / UDI-DI
D661PX2000
Basic UDI-DI
++D661019KN
FDA Product Code
NDP
EMDN Code
Q01010199 Dental restoration devices - other
GMDN Term
Dental laboratory power tool system
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000015761
Authorised representative
Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

Related devices

Category: Dental appliance fabrication material, ceramic

Other devices from Coltene/Whaledent Inc.

See all devices from Coltene/Whaledent Inc. →

Properties

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