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R2 Tray R2TRAYSE

by Megagen Implant Co. Ltd

Ref R2TRAYSE

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899235Q9 Basic UDI-DIDate20 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809708759126 UDI-DIDate1 Jul 2021ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
R2 Tray
Generic Name
Fixture/appliance dental drill bit, reusable
Device Name
Tray
Model / Ref / Catalog
R2TRAYSE
Primary DI / UDI-DI
08809708759126
Basic UDI-DI
880972899235Q9
FDA Product Code
EHY
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
GMDN Term
Fixture/appliance dental drill bit, reusable
Device Class
Class I
Regulation Number
872.6880
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Fixture/appliance dental drill bit, reusable

Other devices from Megagen Implant Co., Ltd.

See all devices from Megagen Implant Co., Ltd. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Expiration Date: No