Alfa Triple Tray 9046085

by Premier Dental Products Company

Ref 9046085

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number00348783AlfaTripleTray5L Basic UDI-DI 00348783012033UDI-DI	Date27 May 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00348783012033 UDI-DI	Date29 Jun 2022Listed	StatusListed GUDID: not 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

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: ALFA Sample-2 medium, one small and one large EUDAMED
Alfa Triple Tray GUDID
Generic Name: Dental impression tray, single-use
Model / Reference: 9046085

Primary DI / UDI-DI: 00348783012033 EUDAMED
D6919046085 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: Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Primary DI / UDI-DI	EUDAMED 00348783012033	GUDID D6919046085

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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