No Certificate Found

Snapshot 2026-10-11 · Link to EUDAMED

BiWaze Clear System

UDI-DI +B965BK9390Basic UDI-DI ++B965BK940VX

Class IIa · MDR · ABMRC LLC

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Identification

Model: BK940, BK939
EMDN: R05010302
Issuing agency: HIBCC
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-11 · Link to EUDAMED

Manufacturer

SRN US-MF-000012891

US · Eagan, Minnesota

manufacturer

Authorised representative: Porta Medical UG (DE-AR-000005279)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/biwaze-clear-system-9390 · UDI page: /udi/%2BB965BK9390

All devices from ABMRC LLC

Scan an inventory CSV