Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Penumbra Coil 400 Complex Soft 5 mm x 13 cm

UDI-DI 00815948028586Basic 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
PAC400 7 cm 00815948028043
Packing Coil 15 cm 00815948024717
Packing Coil 30 cm 00815948024724
Packing Coil 45 cm 00815948024731
Packing Coil 5 cm 00815948024694

Showing 12 of 250 other UDI-DIs.

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Canonical device page: /device/penumbra-coil-400-complex-soft-5-mm-x-13-cm-8586 · UDI page: /udi/00815948028586

All devices from Penumbra, Inc.

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