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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Bioptimal Bipolar Pacing Catheter

UDI-DI 08886483551800Basic UDI-DI 888648350907SB

Class III · MDR · Bioptimal International PTE. LTD.

Identification
Model
BP2502-10 / BP2502CS-10 / BPX2502-10 / BPX2502CS-10
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

2283440TD01

EU technical documentation assessment · unknown

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

Valid from 2026-04-09 · Expiry 2031-03-01

Scope not stated in certificate data.

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

2283440CE01

EU quality management system · valid

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

Valid from 2026-03-24 · Expiry 2031-03-01

Scope not stated in certificate data.

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

Manufacturer

Bioptimal International PTE. LTD.

SRN SG-MF-000010306

SG · Singapore

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/bioptimal-bipolar-pacing-catheter-1800 · UDI page: /udi/08886483551800

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