Skip to content

EndoRotor® Console ERC 20-01

by Interscope

Ref ESS-CONSOLE

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

CE MDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0854172008EndoRotor7L Basic UDI-DI 00865830000220UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00865830000220 UDI-DI Date2 Aug 2019ListedStatusListed 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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
EndoRotor Console EUDAMED
EndoRotor® Console GUDID
EndoRotor® EndoSurgery System - Console GUDID
Generic Name
Tissue morcellation system control unit
Model / Ref / Catalog
ESS-CONSOLE, ERC 20-01
Primary DI / UDI-DI
00865830000220, 00854172008216
Basic UDI-DI
0854172008EndoRotor7L
Direct Marketing DI
00865830000220
FDA Product Code
PTE
EMDN Code
G030899 Instruments for gastro-intestinal endoscopy and eco-endoscopy, single-use - other
GMDN Term
Tissue morcellation system control unit
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
884.1690
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Interscope

See all devices from Interscope →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Expiration Date: No