Shape Memory Medical Inc devices, product family

by Shape Memory Medical Inc 7 variants Basic UDI-DI 081004165IMP8Z

Shared by every variant

Manufacturer: Shape Memory Medical Inc(7)
Basic UDI-DI: 081004165IMP8Z
Risk class: Class IIClass IIb (varies)
Legislation: MDD
EMDN category: PERIPHERAL VASCULAR SYSTEM TOTAL CHRONIC OCCLUSION DEVICES
Market status: 7 on the market
Official record: EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 081004165IMP8Z.

2 certificates naming this Basic UDI-DI · EUDAMED

1000156813 Quality management system · refdata.applicable-legislation.mdr issued
Notified body 0297 · holder Shape Memory Medical Inc · issued 19 Dec 2025 · expires 18 Dec 2030
1000275865 Technical documentation · refdata.applicable-legislation.mdr issued
Notified body 0297 · holder Shape Memory Medical Inc · issued 19 Dec 2025 · expires 18 Dec 2030

0 recalls · FDA

No recall matched the devices on this page.

Recalls matched to the 7 devices listed on this page; other pages of the family can carry others.

7 devices · page 1 of 1

Variants of Shape Memory Medical Inc devices, Basic UDI-DI 081004165IMP8Z
		UDI-DI	Size and differences
IMPEDE Embolization Plug IMP-05	IMP-05 / IMP-05	00810041650009	—	On the market
IMPEDE Embolization Plug IMP-07	IMP-07 / IMP-07	00810041650016	—	On the market
IMPEDE Embolization Plug IMP-10	IMP-10 / IMP-10	00810041650023	—	On the market
IMPEDE-FX Embolization Plug	IMP-FX-06 / IMP-FX-06	00810041650030	—	On the market
IMPEDE-FX Embolization Plug	IMP-FX-08 / IMP-FX-08	00810041650047	—	On the market
IMPEDE-FX Embolization Plug IMP-FX-12	IMP-FX-12 / IMP-FX-12	00810041650054	—	On the market
IMPEDE-FX RapidFill	IMP-FX-12X5 / IMP-FX-12x5	00810041650399	—	On the market