Skip to content

SANDEL Skin Marker (Sterile)

by Ansell Healthcare Europe NV

Ref 1019, 1019-NNS

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 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 Number5414566SANSKMSTR106Q Basic UDI-DI Date19 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number25414566830060 UDI-DI Date25 Mar 2022ListedStatusListed 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.

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  • Withdrawn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
SANDEL Skin Marker (Sterile) EUDAMED
SANDEL Skin Marker EUDAMED
Sandel GUDID
Generic Name
Skin marking pen, single-use
Device Name
SANDEL Skin Markers (Sterile)
SANDEL Skin Markers (Non-Sterile)
Model / Ref / Catalog
1019, 1019-NNS
Primary DI / UDI-DI
25414566830060, 25414566830138
Basic UDI-DI
5414566SANSKMSTR106Q, 5414566SANSM10YD
FDA Product Code
FZZ
EMDN Code
V9004 Skin marking dermographic pencils and pens
GMDN Term
Skin marking pen, single-use
Device Class
Class I
Regulation Number
878.4660
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
SterileEUDAMED
Yes
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
BE-MF-000000691

Other devices from Ansell Healthcare Europe NV

See all devices from Ansell Healthcare Europe NV →

Properties

  • Sterile YesEUDAMEDGUDIDNoEUDAMED
  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No