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Nuprep Skin Prep Gel

by Weaver and Company United States EUDAMEDGUDID

Ref 10-91, 10-91S Product code DRXEMDN Z12100385

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00891893002284 UDI-DIDate17 Nov 2023ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number08918930021030SV Basic UDI-DIDate6 Mar 2023RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Electrode conductive medium
Model / Reference
10-91, 10-91S, 10-91K
Primary DI / UDI-DI
00891893002284
Basic UDI-DI
08918930021030SV
Direct Marketing DI
00891893002284
510(k) Number
FDA Product Code
DRX
EMDN Code
Z12100385 Electroencephalography instruments - consumables
GMDN Term
Electrode conductive medium
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2360
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
10-91, 10-91S
GUDID
10-91; 10-91K
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000013815
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Weaver and Company

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 3558fcaf-1ffd-4bf1-9dda-d36bd99a74f5 61 fields · synced 22 Oct 2026
  • FDA UDI b5bcc264-ddb0-4fe2-beae-dee1cee70ccd 35 fields · synced 30 May 2026