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Flexible Block Monolayer

by Shandong Huge Dental Material Corporation EUDAMEDGUDID

Active European Union

Ref Monolayer/98×20/2S/Pink/1×1/BoxModel Monolayer

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6909412RXSZK2A015A Basic UDI-DIDate28 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06909412305847 UDI-DIDate26 Oct 2025ListedStatusListed 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  • Withdrawn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 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Flexible Block
Generic Name
Dental appliance fabrication material, resin
Model / Ref / Catalog
Monolayer, Monolayer/98×20/2S/Pink/1×1/Box, 98*20 2S/Pink/1x1/Box
Primary DI / UDI-DI
06909412305847
Basic UDI-DI
6909412RXSZK2A015A
510(k) Number
FDA Product Code
EBI
EMDN Code
Q0102050199 Dentistry resins - other
GMDN Term
Dental appliance fabrication material, resin
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3760
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Shandong Huge Dental Material Corporation

See all devices from Shandong Huge Dental Material Corporation →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No