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PainChek

by PainChek Ltd. 2 variants

Ref PainChek Adult (iOS Version)Model PainChek Adult

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09360350000015 UDI-DI Date18 May 2026ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDD EUDAMED NumberB-09360350000015 Basic UDI-DI 09360350000015UDI-DIDate27 Feb 2026RegisteredStatusActive

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 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Image-based pain-assessment software
Model / Reference
PainChek Adult EUDAMED
PainChek Adult (iOS Version) EUDAMED
PainChek Adult iOS GUDID
Primary DI / UDI-DI
09360350000015
Basic UDI-DI
B-09360350000015
De Novo Number
FDA Product Code
SGB
EMDN Code
V92 Medical device software - not included in other classes
GMDN Term
Image-based pain-assessment software
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1472
Special Device Type
-1192
EU market of registration
Italy
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PainChek Adult
PainChek Adult (iOS Version)
GUDID
PainChek Adult iOS
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
AU-MF-000034893
Authorised representative
Donawa Lifescience Consulting Srl IT-AR-000007785

Other devices from Painchek Ltd

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number

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
  • Expiration Date: No
  • Manufacturing Date: No