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Skin Marker

by GRI Medical & Electronic Technology Co., Ltd. 5 variants

Ref 25-D001-S, 25-D002, 25-D002-S, 25-S001BB, 25-S002-S

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 Number69319181F027L5 Basic UDI-DI Date26 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number16931918139296 UDI-DI Date4 Feb 2021ListedStatusListed 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  • Withdrawn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
Alleset
Generic Name
Skin marking pen, single-use
Model / Reference
25-D001-S EUDAMED
25-D002 EUDAMED
25-D002-S EUDAMED
25-S001BB EUDAMED
25-S002-S EUDAMED
Model 25-S002-S GUDID
Primary DI / UDI-DI
16931918139296, 16931918175805, 16931918173047, 16931918156798, 16931918181158
Basic UDI-DI
69319181F027L5
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
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
25-D001-S
25-D002
25-D002-S
25-S001BB
25-S002-S
GUDID
Model 25-S002-S
SterileEUDAMED
Yes
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
CN-MF-000004203
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from GRI Medical & Electronic Technology Co., Ltd.

See all devices from GRI Medical & Electronic Technology Co., Ltd. →

Properties

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

Other properties (19)

  • 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