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PET Kit MKPET3000M

by Megagen Implant Co. Ltd

Ref MKPET3000M

PET Kit MKPET3000M is a device classified as Class IIa in the EU and Class I in the US made by Megagen Implant Co. Ltd, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 880972899843B) and listed in FDA GUDID since 1 Jul 2025 (UDI-DI 08800293008187), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899843B Basic UDI-DI 08800293008187UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800293008187 UDI-DI Date1 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880972899843B registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 08800293008187 listed 1 Jul 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800293008187
  2. Registered EUDAMED 880972899843B

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  • Withdrawn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
PET Kit
Generic name
Fixture/appliance dental drill bit, reusable
Model / Ref / Catalog
MKPET3000M
Primary DI / UDI-DI
08800293008187
Basic UDI-DI
880972899843B
FDA product code
NDP
EMDN code
L159016 Dental surgery instrument kits, reusable
GMDN term
Fixture/appliance dental drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Fixture/appliance dental drill bit, reusable

Similar devices in this category

Other devices filed under DENTAL SURGERY INSTRUMENT KITS, REUSABLE.

Other devices from Megagen Implant Co., Ltd.

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

Properties

  • Sterilise before use
  • Single use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (17, all answered No)