No Certificate Found

Snapshot 2026-10-10 · Link to EUDAMED

Legacy device

i.Series

UDI-DI 00816394021107Basic UDI-DI B-00816394021107

Class IIa · MDD (legacy) · Helmer Scientific

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Identification

Model: iBR113-GX
EMDN: Z121701
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Manufacturer

Helmer Scientific

SRN US-MF-000003326

US · Noblesville

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

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/i-series-1107 · UDI page: /udi/00816394021107

All devices from Helmer Scientific

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