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Comfort Marker 2.0 Control Unit and Pen

by Medical Precision B.V. EUDAMEDGUDID

Active European Union

Ref 2011Model Comfort Market 2.0

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08720165025022 Basic UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08720165025022 UDI-DIDate12 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Comfort Marker 2.0 Control Unit and Pen EUDAMED
Medical Precision Comfort Marker GUDID
Generic Name
Tattoo ink injector
Device Name
Comfort Market 2.0 Control Unit and Pen
Model / Ref / Catalog
Comfort Market 2.0, 2011, 2.0
Primary DI / UDI-DI
08720165025022
Basic UDI-DI
B-08720165025022
FDA Product Code
QRN
EMDN Code
Z119099 Various bioimaging and radiotherapy instruments - other
GMDN Term
Tattoo ink injector
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.5785
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Comfort Market 2.0
2011
GUDID
2.0
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000010825

Other devices from Medical Precision BV

See all devices from Medical Precision BV →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Lot / Batch Number: No
  • Expiration Date: No