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Single Use Brush Biopsy Instrument TNE-110

by Endo-Therapeutics, Inc.

Ref TNE-110

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816207021690 Basic UDI-DI 00816207021690UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816207021690 UDI-DI Date9 Dec 2022ListedStatusListed GUDID: not 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.

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  • Withdrawn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
Single Use Brush Biopsy Instrument
Generic Name
Flexible endoscopic cytology brush, single-use
Device Name
Biopsy Brush
Model / Ref / Catalog
TNE-110
Primary DI / UDI-DI
00816207021690
Basic UDI-DI
B-00816207021690
FDA Product Code
GEE
EMDN Code
G03080399 Gastrointestinal endoscopy and echoendoscopy, brushes - other
GMDN Term
Flexible endoscopic cytology brush, single-use
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Malta
GUDID distribution status
Not in Commercial Distribution
Size
Length — 110 Centimeter

Other devices from Endo-Therapeutics, Inc.

See all devices from Endo-Therapeutics, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No