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Diode Laser Tips - Pre Initiated Tips

by Biolase Mg LLC 2 variants

Ref 6400605

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 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/MDD EUDAMED NumberB-00647529003220 Basic UDI-DI 00647529003220UDI-DIDate20 Feb 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00647529003220 UDI-DI Date21 May 2018ListedStatusListed 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Diode Laser Tips - Pre Initiated Tips EUDAMED
Diode Laser Tips GUDID
Generic Name
Dental diode laser system
Device Name
Diode Laser Tips, PI Pro Tips Starter Kit, 10PK
Model / Ref / Catalog
6400605, PI Pro Tips, Starter Kit
Primary DI / UDI-DI
00647529003220
Basic UDI-DI
B-00647529003220
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011099 Laser surgery instruments - other
GMDN Term
Dental diode laser system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 300 Micrometer
Outer Diameter — 400 Micrometer
Length — 4 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
6400605
GUDID
PI Pro Tips, Starter Kit
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000028587
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Biolase Mg LLC

See all devices from Biolase Mg LLC →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (18)

  • Sterile: 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No