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Testi10™

by Rigicon, Inc. United States EUDAMED

Ref TESTIS-XLModel Size: XLarge (32*51 mm)

EMDN P080201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00850015358791 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Testi10™ Saline Testicular Prosthesis
Model / Reference
Size: XLarge (32*51 mm), TESTIS-XL
Primary DI / UDI-DI
00850015358791
Basic UDI-DI
B-00850015358791
EMDN Code
P080201 Testicle prostheses
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
US-MF-000027758
Authorised representative
Rigicon B.V. NL-AR-000013173

Other devices from Rigicon, Inc.

See all devices from Rigicon, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • 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

Sources (1)

  • EUDAMED c455ed8b-a3d5-4bcc-b006-0eae08607982 61 fields · synced 22 Oct 2026