Identity
- Trade Name
- Spex EUDAMED
- Model / Reference
- WGM, WMC, SPX, SPN, SLP EUDAMEDSPN35135CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850025525305 EUDAMED
- Basic UDI-DI
- 856492005SupportCathKP EUDAMED
- EMDN Code
- C0104020202 PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spex by Reflow Medical, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 856492005SupportCathKP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Reflow Medical, Inc.
- EUDAMED SRN
- US-MF-000017521
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED 3f0e4e8d-79ef-4e45-804e-469539d0c73f 61 fields · synced May 23, 2026