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Reveel

by Microline Surgical, Inc. 2 variants

Ref RT083001Model Laparoscopic Retractor- Percutaneous

Reveel (RT083001) is a device classified as Class IIa in the EU and Class II in the US made by Microline Surgical, Inc., registered in EUDAMED on 19 Sep 2025 (Basic UDI-DI 081109901DOC013SC) with CE/MDR certificate 3841767CE01 valid until 6 Sep 2031, cleared under FDA 510(k) K133345 on 11 Apr 2014 and listed in FDA GUDID since 22 Sep 2025 (UDI-DI 00811099014416), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

6 Sep 2031

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K133345

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3841767CE01 Date6 Sep 2026IssuedStatusActive expires 6 Sep 2031
United StatesGUDID listing GUDID Number00811099014416 UDI-DI Date22 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK133345 Date11 Apr 2014IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081109901DOC013SC registered 19 Sep 2025 Active· +1 more in the status table
  • FDA 510(k) K133345 decided 11 Apr 2014 Active
  • FDA GUDID UDI-DI 00811099014416 listed 22 Sep 2025 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3841767CE01 Active Reissued

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    6 Sep 2026
    Expires
    6 Sep 2031

Timeline

5 dated events

  1. Cleared FDA 510(k) K133345
  2. Registered EUDAMED 081109901DOC013SC
  3. Listed FDA GUDID 00811099014416
  4. Certificate issued EUDAMED 3841767CE01
  5. Certificate expires EUDAMED 3841767CE01

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Reveel EUDAMED
REVEEL - Endoscopic Retractor - Trocar GUDID
Generic name
Hand-held endoscopic retractor, single-use
Device name
REVEEL Laparoscopic Retractor
Model / reference
Laparoscopic Retractor- Percutaneous, RT083001
Primary DI / UDI-DI
00811099014416
Basic UDI-DI
081109901DOC013SC
Unit of use DI
00811099014409
510(k) Number
FDA product code
GCJ
EMDN code
K01020106 Minimally invasive surgery spreaders and retractors, single-use
GMDN term
Hand-held endoscopic retractor, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
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

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000009811
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE.

Other devices from Microline Surgical, Inc.

  • ReNew 3412

    Class II

  • ReNew 3362

    Class II

  • ReNew 3946

    Class II

  • ReNew 3411

    Class II

See all devices from Microline Surgical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)