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Sign in to claim this brandShape Memory Medical Inc
United States·US-MF-000008157
Last updated September 17, 2026
What Shape Memory Medical Inc makes
Shape Memory Medical Inc manufactures single-use extraluminal vascular occluders. Their product portfolio includes the IMPEDE and IMPEDE-FX series of embolization plugs and the IMPEDE-FX RapidFill device.
The company is based in the United States and maintains device listings in the FDA 510(k) and UDI databases, as well as EUDAMED. These products are categorized under Class II and Class IIb regulatory classifications.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of medical devices does Shape Memory Medical Inc manufacture?
Shape Memory Medical Inc specializes in the production of single-use extraluminal vascular occluders. Their current product portfolio features the IMPEDE and IMPEDE-FX series of embolization plugs, as well as the IMPEDE-FX RapidFill device, which are designed for specific vascular applications.
Where is Shape Memory Medical Inc located?
Shape Memory Medical Inc is based in the United States. This location serves as the primary base for the company's operations and regulatory filings for its vascular occlusion product line.
Which regulatory registries include devices from Shape Memory Medical Inc?
The company maintains device listings across several major regulatory databases to ensure transparency and compliance. These include the FDA 510(k) database, the FDA UDI database, and the European database on medical devices, EUDAMED.
How are the devices from Shape Memory Medical Inc classified?
The devices manufactured by Shape Memory Medical Inc are categorized under Class II and Class IIb regulatory classifications. These classifications are assigned based on the regulatory requirements for the specific types of extraluminal vascular occluders the company produces.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- Suite 10, 1321 Ridder Park Dr., San Jose, United States
- Website
- shapemem.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Meghan Reu
- EUDAMED SRN
- US-MF-000008157
- FDA FEI Number
- 3013353964
- DUNS Number
- —
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| IMPEDE Embolization Plug | IMP-10 | FDA UDI | Class II | Active |
| IMPEDE Embolization Plug | IMP-05 | FDA UDI | Class II | Active |
| IMPEDE-FX Embolization Plug | IMP-FX-12 | FDA UDI | Class II | Unknown |
| IMPEDE Embolization Plug | IMP-07 | FDA UDI | Class II | Active |
| IMPEDE-FX Embolization Plug | IMP-FX-12 | FDA UDI | Class II | Active |
| IMPEDE Embolization Plug | IMP-10 | FDA UDI | Class II | Unknown |
| IMPEDE Embolization Plug | IMP-07 | FDA UDI | Class II | Unknown |
| IMPEDE Embolization Plug | IMP-05 | FDA UDI | Class II | Unknown |
| IMPEDE-FX Embolization Plug | IMP-FX-06 | FDA UDI | Class II | Active |
| IMPEDE-FX Embolization Plug | IMP-FX-08 | FDA UDI | Class II | Unknown |
| IMPEDE-FX Embolization Plug | IMP-FX-06 | EUDAMEDFDA UDI | Class IIb | Active |
| IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm | K181051 | FDA 510(k) | Class II | Active |
| IMPEDE-FX RapidFill | IMP-FX-12X5 | EUDAMED | Class IIb | Active |
| IMPEDE-FX Embolization Plug | IMP-FX-08 | EUDAMEDFDA UDI | Class IIb | Active |
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