Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

PAC400 7 cm

UDI-DI 00815948028043Basic UDI-DI 081454801PCOEU

Class III · MDR · Penumbra, Inc.

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Identification

Model: Embolization Coils
EMDN: C010402020301
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 739883

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-06-22 · Expiry 2028-03-28

Scope not stated in certificate data.

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

Manufacturer

SRN US-MF-000008514

US · Alameda

manufacturer

Authorised representative: Penumbra Europe GmbH (DE-AR-000004997)

Related UDI-DIs

PAC400 10 cm 00815948028203
PAC400 15 cm 00815948028210
PAC400 25 cm 00815948028227
PAC400 35 cm 00815948028234
PAC400 40 cm 00815948028241
PAC400 50 cm 00815948028265
PAC400 60 cm 00815948028272
Packing Coil 15 cm 00815948024717
Packing Coil 30 cm 00815948024724
Packing Coil 45 cm 00815948024731
Packing Coil 5 cm 00815948024694
Packing Coil 60 cm 00815948024748

Showing 12 of 250 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/pac400-7-cm-8043 · UDI page: /udi/00815948028043

All devices from Penumbra, Inc.

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