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Sesis

by SurgEase Innovations Ltd.

Ref SIS-CSB-101Model SESIS

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506076828SESISFS Basic UDI-DI 05060768280576UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060768280576 UDI-DI Date9 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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

Generic Name
Suction/irrigation tubing, single-use
Device Name
SurgEase Endoscopic Suction Irrigation System
Model / Reference
SESIS, SIS-CSB-101
Primary DI / UDI-DI
05060768280576
Basic UDI-DI
506076828SESISFS
FDA Product Code
FCZ
EMDN Code
A0601010201 Drainage systems with adjustable suction and collection chamber
GMDN Term
Suction/irrigation tubing, single-use
Device Class
Class I
Regulation Number
876.1500
EU market of registration
Lithuania
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
GB-MF-000016541
Authorised representative
Advena SRL IT-AR-000051131

Other devices from Surgease Innovations Limited

See all devices from Surgease Innovations Limited →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: 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
  • Serial Number: No
  • Expiration Date: No