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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

GEM Microvascular Anastomic COUPLER

UDI-DI 00844735006391Basic UDI-DI 478180000000000000001157R

Class IIb · MDR · Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.)

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

MDR 778466

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-06-16 · Expiry 2030-04-22

Scope not stated in certificate data.

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

Manufacturer

Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.)

SRN US-MF-000034162

US · BIRMINGHAM (AL)

manufacturer

Authorised representative: Baxter Deutschland GmbH (DE-AR-000010308)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/gem-microvascular-anastomic-coupler-6391 · UDI page: /udi/00844735006391

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