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Senhance X9007022

by Asensus Surgical, Inc.

Ref X9007022Model Senhance Adapters

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081544002TD006UP Basic UDI-DI 00815440021368UDI-DIDate25 Jan 2022RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00815440021368 UDI-DI Date2 Nov 2018ListedStatusListed 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  • Withdrawn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  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Adapter, Passive Needle Holder Left Ø 5 mm x 240 mm EUDAMED
Senhance GUDID
Generic Name
Robotic surgical telemanipulation system
Device Name
Adapter, Allis Grasper Ø 5 mm x 240 mm
Model / Ref / Catalog
X9007022, Senhance Adapters, 200-21094
Primary DI / UDI-DI
00815440021368
Basic UDI-DI
081544002TD006UP
Direct Marketing DI
00815440021368
FDA Product Code
NAY
EMDN Code
Z1202018099 Remote control robot-assisted endoscopic surgery instruments - hardware accessories - other
GMDN Term
Robotic surgical telemanipulation system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Asensus Surgical, Inc.

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