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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

BioProtect Balloon Implant System

UDI-DI 07290014878013Basic UDI-DI 7290014878BP0135V3

Class III · MDR · BioProtect

Identification
Model
—
EMDN
V9099
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

3902997TD01

EU technical documentation assessment · valid

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

Valid from 2024-08-14 · Expiry 2029-08-01

Scope not stated in certificate data.

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

3902997CE01

EU quality management system · valid

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

Valid from 2024-08-14 · Expiry 2029-08-01

Scope not stated in certificate data.

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

Manufacturer

BioProtect

SRN IL-MF-000013165

IL · Netanya

manufacturer

Authorised representative: CEpartner4U (NL-AR-000000111)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/bioprotect-balloon-implant-system-8013 · UDI page: /udi/07290014878013

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