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DS Tip DS-XRE

by B& L Biotech, inc.

DS Tip DS-XRE is a Class I device made by B& L Biotech, inc., registered in EUDAMED and listed in FDA GUDID since 30 Apr 2025 (UDI-DI 08800019151661), active as of 23 Oct 2026.

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

CE MDR CE MDD

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
United StatesGUDID listing GUDID Number08800019151661 UDI-DI Date30 Apr 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800019151661 listed 30 Apr 2025 Listed

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
DS Tip
Generic name
Dental ultrasonic surgical system
Model / reference
DS-XRE
Primary DI / UDI-DI
08800019151661
FDA product code
JET
GMDN term
Dental ultrasonic surgical system
Device class
Class I
Regulation number
872.6650
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental ultrasonic surgical system

Other devices from B&L Biotech Co., Ltd.

See all devices from B&L Biotech Co., Ltd. →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)