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REVEEL Endoscopic Retractor

by Retraction Limited 2 variants

Ref RT083001Model RV093001

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133345↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number489705430REVEELQC Basic UDI-DI 04897054300837UDI-DIDate21 Dec 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK133345 Date11 Apr 2014IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
REVEEL Endoscopic Retractor
Model / Reference
RV093001, RT083001
Primary DI / UDI-DI
04897054300837
Basic UDI-DI
489705430REVEELQC
EMDN Code
K01020106 Minimally invasive surgery spreaders and retractors, single-use
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
HK-MF-000038989
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Retraction Limited

Properties

  • Sterile

Other properties (12)

  • 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