Skip to content

SafePrep - Abrasive skin gel

by Spes Medica S.p.A.

Ref NPREP010E-1

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8054655000012XV Basic UDI-DI 18054655031840UDI-DIDate21 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number18054655031840 UDI-DI Date5 Aug 2021ListedStatusListed 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  • Withdrawn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

Trade Name
SafePrep - Abrasive skin gel EUDAMED
SafePrep GUDID
Generic Name
Electrode conductive medium
Device Name
Gel and Creams
Model / Reference
NPREP010E-1
Primary DI / UDI-DI
18054655031840
Basic UDI-DI
8054655000012XV
FDA Product Code
KOY
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Electrode conductive medium
Device Class
Class I
Regulation Number
878.4730
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
IT-MF-000008858

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Spes Medica S.p.A.

See all devices from Spes Medica S.p.A. →

Properties

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

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No