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ZSI 100 D4 - Malleable penile implant

by Zephyr Surgical Implants sàrl

Ref ZSI 100 D4

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-ZSI100-D4BB Basic UDI-DI D-ZSI100-D4BBUDI-DIDate12 Aug 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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Malleable penile implant
Model / Reference
ZSI 100 D4
Primary DI / UDI-DI
D-ZSI100-D4BB
Basic UDI-DI
B-ZSI100-D4BB
EMDN Code
P080202 Penile prostheses
Device Class
Class IIb
EU market of registration
France

Manufacturer details

EUDAMED SRN
CH-MF-000026382
Authorised representative
ZEPHYR SURGICAL IMPLANTS FR-AR-000000816

From the manufacturer

Manufacturer's product page: ZSI 100 - Malleable penile implant (semi-rigid)

Other devices from Zephyr Surgical Implants sàrl

See all devices from Zephyr Surgical Implants sàrl →

Properties

  • 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