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WipeClean™ HZ2842+1+SPUP+2200

by F.r.galantai Manufacturing Company Limited

Ref HZ2842+1+SPUP+2200Model Single Patient Use Pack

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
United StatesGUDID listing GUDID Number09421028494625 UDI-DI Date9 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number942102849MDCCBPPFU Basic UDI-DI 09421028494625UDI-DIDate30 Mar 2023RegisteredStatusActive

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  • Withdrawn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

Trade Name
Wipe Clean EUDAMED
WipeClean™ GUDID
Generic Name
Surgical instrument/endoscope cleaning utensil, single-use
Model / Reference
HZ2842+1+SPUP+2200, Single Patient Use Pack
Description
1 x Channel cleaning brush, channel ID 2.8-4.2mm, length 2200mm - Single Patient User Pack 1 x Port cleaning brush
Primary DI / UDI-DI
09421028494625
Basic UDI-DI
942102849MDCCBPPFU
FDA Product Code
MNL
EMDN Code
V070101 Endoscopes cleaning brushes - for generic use
GMDN Term
Surgical instrument/endoscope cleaning utensil, single-use
Device Class
Class I
Regulation Number
876.1500
Medical Purpose
The contents of the procedure pack are single use brushes intended for the manual cleaning of endoscopes and other medical instruments which may have internal channels.
GUDID distribution status
In Commercial Distribution

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Properties

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

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No