Identity
- Trade Name
- IMPEDE-FX RapidFill EUDAMED
- Device Name
- IMPEDE-FX RapidFill EUDAMED
- Model / Reference
- IMP-FX-12x5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810041650399 EUDAMED
- Basic UDI-DI
- B-00810041650399 EUDAMED
- EMDN Code
- C0104020209 PERIPHERAL VASCULAR SYSTEM TOTAL CHRONIC OCCLUSION DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
IMPEDE-FX RapidFill by Shape Memory Medical Inc — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00810041650399 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shape Memory Medical Inc
- EUDAMED SRN
- US-MF-000008157
- Authorised Representative
- MedR-AR Services B.V. NL-AR-000000120
Sources (1)
- EUDAMED e698e12b-8f46-4e27-8fb6-495c5d8d12e4 61 fields · synced Jun 19, 2026