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Point Digit - 85mm - Gunmetal

by Point Designs, Inc. United States EUDAMED

Ref PNTDG2-085-GModel Point Digit EMDN Y061803

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081006742PointDigitF3 Basic UDI-DIDate18 Jan 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Point Digit
Model / Reference
Point Digit, PNTDG2-085-G
Primary DI / UDI-DI
00810067420129
Basic UDI-DI
081006742PointDigitF3
EMDN Code
Y061803 Partial hand prostheses (including fingers prostheses)
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000013587
Authorised representative
mdi Europa GmbH DE-AR-000006218

From the manufacturer

Manufacturer's product page: Point Digit

Other devices from Point Designs, Inc.

See all devices from Point Designs, Inc. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: 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

Sources (1)

  • EUDAMED a1d7a65c-3593-4b60-b148-df911dd01008 61 fields · synced 22 Oct 2026