hyamax® Vaxel

Identification

Model: 0.5mL/M010401;1mL/M010402;1.5mL/M010403;2mL/M010404;2.5mL/M010405;3mL/M010406;
EMDN: X0301
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 827250

EU technical documentation assessment · valid

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

Valid from 2026-06-29 · Expiry 2031-06-28

Scope not stated in certificate data.

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

Manufacturer

SRN CH-MF-000039052

CH · Genève

manufacturer

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

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