Unknown / Not in EUDAMED

Snapshot 2026-10-09 · Link to EUDAMED

EspiForte

UDI-DI 04251778103882Basic UDI-DI 42517781MD301CF

Class III · MDR · HÄLSA Pharma GmbH

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Identification

Model: Simeticone Capsules
EMDN: G0401
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

20416GB450260423

EU technical documentation assessment · unknown

Notified body: DNV MEDCERT GmbH (0482)

Valid from 2026-04-23 · Expiry 2029-02-26

Scope not stated in certificate data.

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

Manufacturer

HÄLSA Pharma GmbH

SRN DE-MF-000007407

DE · Luebeck

manufacturer

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/espiforte-3882 · UDI page: /udi/04251778103882

All devices from HÄLSA Pharma GmbH

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