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Nuprep Skin Prep Gel

by Weaver and Company 3 variants

Ref 10-61, 10-25, 10-25S, 10-65

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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 Number08918930021030SV Basic UDI-DI 00891893002246UDI-DIDate6 Mar 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00891893002246 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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

Generic Name
Electrode conductive medium
Model / Ref / Catalog
10-61, 10-25, 10-25S, 10-65
Primary DI / UDI-DI
00891893002246
Basic UDI-DI
08918930021030SV
Direct Marketing DI
00891893002246
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
10-61, 10-25, 10-25S, 10-65
GUDID
10-25; 10-25S; 10-61
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

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • Sterile: No
  • Single Use: 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