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Overlay TF

by Ethnocare Inc. EUDAMED

Active European Union

Ref OVTF-38-LG-VAC, OV23-LG-R, OVTF-38-LG-PIN, OVTF-44-SH-VAC, OVTF-52-LG-VAC, OV35-SH-R, OVTF-48-LG-VAC, OVTF-52-SH-VAC, OVTF-40-XL-PIN, OVTF-32-SH-PIN, OV28-LG-L, OVTF-44-XL-PIN, OVTF-44-LG-PIN, OVTF-40-LG-PIN, OV35-SH-L, OVTF-32-SH-VAC, OVTF-52-LG-PIN, OVTF-48-SH-VAC, OVTF-52-SH-PIN, OVTF-52-XL-PIN, OVTF-44-LG-VAC, OVTF-38-XL-PIN, OV23-LG-LModel Overlay TF, Overlay

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number628693190OVERLAYTF8S Basic UDI-DIDate6 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Trade Name
Overlay TF
Overlay
Model / Reference
Overlay TF, OVTF-38-LG-VAC, Overlay, OV23-LG-R, OVTF-38-LG-PIN, OVTF-44-SH-VAC, OVTF-52-LG-VAC, OV35-SH-R, OVTF-48-LG-VAC, OVTF-52-SH-VAC, OVTF-40-XL-PIN, OVTF-32-SH-PIN, OV28-LG-L, OVTF-44-XL-PIN, OVTF-44-LG-PIN, OVTF-40-LG-PIN, OV35-SH-L, OVTF-32-SH-VAC, OVTF-52-LG-PIN, OVTF-48-SH-VAC, OVTF-52-SH-PIN, OVTF-52-XL-PIN, OVTF-44-LG-VAC, OVTF-38-XL-PIN, OV23-LG-L
Primary DI / UDI-DI
00628693190602, 00628693190046, 00628693190374, 00628693190428, 00628693190640, 00628693190107, 00628693190633, 00628693190497, 00628693190534, 00628693190435, 00628693190008, 00628693190565, 00628693190398, 00628693190381, 00628693190114, 00628693190442, 00628693190510, 00628693190466, 00628693190503, 00628693190572, 00628693190626, 00628693190558, 00628693190053
Basic UDI-DI
628693190OVERLAYTF8S, 628693190Overlay9J
EMDN Code
Y062499 Lower extremity prostheses - other
Device Class
Class I
Market of Registration
Germany
Netherlands

Manufacturer details

EUDAMED SRN
CA-MF-000037257
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Ethnocare Inc.

See all devices from Ethnocare Inc. →

Properties

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