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Dental Contra-angle Handpiece

by Guangdong JINME Medical Technology Co., Ltd. 5 variants

Ref W15LWModel W142L/W15L/W11L/W201L/AC142L/AC15L/AC201L/W11L1/W15L1/W15LW/W201/ W142LW1/ W201L1/W41L/W41W/W401LW/AC201L1/AC11L/AC11W4

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971119541019 UDI-DI Date15 Jul 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697111954CAHN7 Basic UDI-DI 06971119541019UDI-DIDate15 Sep 2023RegisteredStatusActive

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 24 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  • Withdrawn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

Trade Name
Dental Contra-angle Handpiece EUDAMED
Dental Handpiece GUDID
Generic Name
Dental surgical power tool motorized handpiece/set, electric
Model / Reference
W142L/W15L/W11L/W201L/AC142L/AC15L/AC201L/W11L1/W15L1/W15LW/W201/ W142LW1/ W201L1/W41L/W41W/W401LW/AC201L1/AC11L/AC11W4, W15LW
Primary DI / UDI-DI
06971119541019
Basic UDI-DI
697111954CAHN7
Direct Marketing DI
06971119541019
510(k) Number
FDA Product Code
EGS, EFB
EMDN Code
Z12110101 Dental treatment units
GMDN Term
Dental surgical power tool motorized handpiece/set, electric
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4200
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000033806
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Guangdong JINME Medical Technology Co., Ltd.

See all devices from Guangdong JINME Medical Technology Co., Ltd. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No