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Henry Schein Maxima

by Henry Schein Inc. EUDAMEDGUDID

Active European Union

Ref 5720874Model TF-295 (HS)

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number03040429501DF Basic UDI-DIDate5 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10304040095574 UDI-DIDate9 Mar 2020ListedStatusListed 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  • Withdrawn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

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

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Henry Schein Maxima EUDAMED
Henry Schein GUDID
Generic Name
Alginate dental impression material
Device Name
Alginates
Model / Ref / Catalog
TF-295 (HS), 5720874
Description
Maxima Alginate Plus - Regular Set, 500 Gm. Refill
Primary DI / UDI-DI
10304040095574 EUDAMED
00304040095577 GUDID
Basic UDI-DI
03040429501DF
Unit of Use DI
00304040095577
FDA Product Code
ELW
EMDN Code
Q01020101 Dental impression alginates
GMDN Term
Alginate dental impression material
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3660
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10304040095574
GUDID
00304040095577
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000021683
Authorised representative
Henry Schein Services GmbH DE-AR-000008001

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Manufacturing Date: No