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EZ-Swivel

by Beyes Dental Inc 8 variants

Ref HP6002Model HP3018

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number99001030147492 Basic UDI-DI 00990010301603UDI-DIDate20 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00990010301603 UDI-DI Date11 May 2023ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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

Generic Name
Pneumatic dental handpiece coupler
Device Name
Quick Coupler
Model / Ref / Catalog
HP3018, HP6002, EZ-Swivel PD B2
Primary DI / UDI-DI
00990010301603
Basic UDI-DI
99001030147492
Direct Marketing DI
00990010301603
510(k) Number
FDA Product Code
EFB
EMDN Code
Z12119099 Various dental stomatology instruments - other
GMDN Term
Pneumatic dental handpiece coupler
Device Class
Class I
Regulation Number
872.4200
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Safe

Manufacturer details

EUDAMED SRN
CA-MF-000001491
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Beyes Dental Inc

See all devices from Beyes Dental Inc →

Properties

  • Reusable
  • Reprocessed
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Expiration Date: No