Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Profemur Gladiator Distal Centralizer

UDI-DI 00192629079458Basic UDI-DI 0192629PROFGDCC76

Class IIb · MDR · MicroPort Orthopedics Inc.

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Identification

Model: —
EMDN: P09088005
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

023-00-00-MDR

EU technical documentation assessment · unknown

Notified body: ITALCERT SRL (0426)

Valid from 2023-07-04 · Expiry 2028-07-03

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

MicroPort Orthopedics Inc.

SRN US-MF-000010240

US · Arlington

manufacturer

Authorised representative: MicroPort Scientific Coöperatief U.A. (NL-AR-000007340)

Related UDI-DIs

Profemur Gladiator Distal Centralizer 00192629079465
Profemur Gladiator Distal Centralizer 00192629079489
Profemur Gladiator Distal Centralizer 00192629079496
Profemur Gladiator Distal Centralizer 00192629079472

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/profemur-gladiator-distal-centralizer-9458 · UDI page: /udi/00192629079458

All devices from MicroPort Orthopedics Inc.

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