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Alfa Triple Tray 1006343

by Premier Dental Products Company EUDAMEDGUDID

Active European Union

Ref 1006343Model 9046085

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00348783AlfaTripleTray5L Basic UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00348783012163 UDI-DIDate29 Jun 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Alfa™ Triple Tray® Assorted – Box of 24 EUDAMED
Alfa Triple Tray GUDID
Generic Name
Dental impression tray, single-use
Model / Reference
1006343, 9046085
Primary DI / UDI-DI
00348783012163 EUDAMED
D6911006343 GUDID
Basic UDI-DI
00348783AlfaTripleTray5L
FDA Product Code
EHY
EMDN Code
Q010503 Impression material trays, single-use
GMDN Term
Dental impression tray, single-use
Device Class
Class I
Regulation Number
872.6880
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00348783012163
GUDID
D6911006343

Related devices

Category: Dental impression tray, single-use

Other devices from Premier Dental Products Company

See all devices from Premier Dental Products Company →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

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