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Alfa Triple Tray 1006313

by Premier Dental Products Company

Ref 1006313Model 9046085

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, self-declared

Class I: no certifier involved

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 Number00348783AlfaTripleTray5L Basic UDI-DI 00348783012132UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00348783012132 UDI-DI Date29 Jun 2022ListedStatusListed 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Alfa™ Triple Tray® Small (Purple) – Box of 24 EUDAMED
Alfa Triple Tray GUDID
Generic Name
Dental impression tray, single-use
Model / Reference
1006313, 9046085
Primary DI / UDI-DI
00348783012132 EUDAMED
D6911006313 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
00348783012132
GUDID
D6911006313

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