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KeyPrint 4200005

by Keystone Industries

Ref 4200005

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-++H66842000051 Basic UDI-DI ++H66842000051UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number++H66842000051 UDI-DI Date20 Dec 2019ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
KeySplint Soft EUDAMED
KeyPrint GUDID
Generic Name
Dental appliance fabrication material, resin
Device Name
3D Resin for printing soft splints
Model / Ref / Catalog
4200005
Primary DI / UDI-DI
++H66842000051 EUDAMED
H66842000051 GUDID
Basic UDI-DI
B-++H66842000051
FDA Product Code
MQC, KMY
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Dental appliance fabrication material, resin
Device Class
Class IIa EUDAMED
U GUDID
Regulation Number
872.5525
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 17.6 Fluid Ounce
Weight — 0.5 Kilogram

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
++H66842000051
GUDID
H66842000051
Device ClassEUDAMED
Class IIa
GUDID
U

Other devices from Keystone Industries

See all devices from Keystone Industries →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Manufacturing Date: No