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UDI Compass

CeraFlex

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 06938370119067Basic UDI-DI 69383701027600WT

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Class III · MDR · Lifetech Scientific (Shenzhen) Co., Ltd.

Identification

Model
PFO Occluder
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No

Certificates

2259149TD11

EU technical documentation assessment · valid

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

Valid from 2025-11-18 · Expiry 2030-11-01

Scope not stated in certificate data.

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

2259152CE05

EU quality management system · unknown

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

Valid from 2025-12-18 · Expiry 2027-08-01

Scope not stated in certificate data.

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

Manufacturer

Lifetech Scientific (Shenzhen) Co., Ltd.

SRN CN-MF-000001561

CN · Shenzhen

manufacturer

Authorised representative: LifeTech Scientific (Europe) B.V. (NL-AR-000000804)

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CeraFlex06938370119074
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CeraFlex06938370119081
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CeraFlex06938370119128
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CeraFlex™ PFO Closure System06938370119050
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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ceraflex-9067 · UDI page: /udi/06938370119067

All devices from Lifetech Scientific (Shenzhen) Co., Ltd.