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DTE D-Laser 16

by Guilin Woodpecker Medical Instrument Co., Ltd.

Ref /Model D-Laser 16

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06944843604473 Basic UDI-DI 06944843604473UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944843604473 UDI-DI Date15 Apr 2026ListedStatusListed 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 25 Oct 2026.

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  • Withdrawn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
D-Laser 16 EUDAMED
Dte GUDID
Generic Name
Dental diode laser system
Device Name
Dental Diode Laser Device
Model / Reference
D-Laser 16, /
Primary DI / UDI-DI
06944843604473
Basic UDI-DI
B-06944843604473
510(k) Number
FDA Product Code
NVK, GEX, ILY
EMDN Code
Z12011016 Diode surgical laser
GMDN Term
Dental diode laser system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810, 890.5500
EU market of registration
Germany
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 IIb
GUDID
Class II

Related devices

Cleared under the same submission (K210367)

Other devices from Guilin Woodpecker Medical Instrument Co., Ltd.

See all devices from Guilin Woodpecker Medical Instrument Co., Ltd. →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No