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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

AFCS PEARLS™ (SAT2) Control Unit

UDI-DI 08720387388165Basic UDI-DI 8720387388SATGQ

Class IIb · MDR · Synergie Nederland

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

2259705CE01

EU quality management system · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2024-11-05 · Expiry 2029-11-01

Scope not stated in certificate data.

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

Manufacturer

Synergie Nederland

SRN NL-MF-000013839

NL · RAAMSDONKSVEER

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/afcs-pearlstm-sat2-control-unit-8165 · UDI page: /udi/08720387388165

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