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HIP Cleaning Solution

by SciCan Ltd. 2 variants

Ref CS-HIPC

HIP Cleaning Solution (CS-HIPC) is a device classified as Class I in the EU and Class II in the US made by Scican Ltd, registered in EUDAMED on 8 Sep 2025 (Basic UDI-DI 7540196HIPFJ) and listed in FDA GUDID since 9 Nov 2020 (UDI-DI 07540196001076), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7540196HIPFJ Basic UDI-DI 07540196001076UDI-DIDate8 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07540196001076 UDI-DI Date9 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7540196HIPFJ registered 8 Sep 2025 Active
  • FDA GUDID UDI-DI 07540196001076 listed 9 Nov 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07540196001076
  2. Registered EUDAMED 7540196HIPFJ

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  • Withdrawn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
HIP Cleaning Solution EUDAMED
Hip GUDID
Generic name
Medical device cleaning agent
Model / Ref / Catalog
CS-HIPC
Description
Hydrim Cleaning Solution with Instrument Protection. For the Hydrim C51.
Primary DI / UDI-DI
07540196001076
Basic UDI-DI
7540196HIPFJ
FDA product code
LDS
EMDN code
Z12011385 Cleaning, disinfection and sterilisation instruments - consumables
GMDN term
Medical device cleaning agent
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6991
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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
CA-MF-000045917
Authorised representative
SciCan GmbH DE-AR-000005428

Similar devices in this category

Other devices filed under CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES.

Other devices from Scican Ltd

See all devices from Scican Ltd →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)