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Spex LP
EUDAMEDClass IIa (EU MDR)
Ref SLP35150CEModel WGM, WMC, SPX, SPN, SLPRef SLP18090CERef SLP18135CERef SLP14150CERef SLP35090CERef SLP35135CERef SLP14090CERef SLP18150CE
Identity
- Trade Name
- Spex LP EUDAMED
- Model / Reference
- WGM, WMC, SPX, SPN, SLP EUDAMEDSLP35150CE EUDAMEDSLP18090CE EUDAMEDSLP18135CE EUDAMEDSLP14150CE EUDAMEDSLP35090CE EUDAMEDSLP35135CE EUDAMEDSLP14090CE EUDAMEDSLP18150CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850025525343 EUDAMED00850025525350 EUDAMED00850025525367 EUDAMED00850025525404 EUDAMED00850025525329 EUDAMED00850025525336 EUDAMED00850025525381 EUDAMED00850025525374 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 LP 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 (8)
- EUDAMED cbc35e0b-505d-4d4f-a427-414069ff30db 61 fields · synced Oct 6, 2026
- EUDAMED d28e933d-411f-441a-95d5-c2bd16f95892 61 fields · synced May 17, 2026
- EUDAMED b5726754-66e6-40f7-a21e-7366b756aca1 61 fields · synced May 18, 2026
- EUDAMED 5ac3c9e3-f090-4f53-9a37-c63f599942e5 61 fields · synced May 18, 2026
- EUDAMED 1f4fb9f0-145c-4f73-9e0e-ac42e9062c4e 61 fields · synced May 18, 2026
- EUDAMED 1e9df68d-db72-4856-a98d-a6e2f06543e6 61 fields · synced May 18, 2026
- EUDAMED de14f23c-5384-4455-82a3-0bb13e612990 61 fields · synced Jul 16, 2026
- EUDAMED cb536e1b-5e98-4caf-8b4e-0a6a86ccc4b6 61 fields · synced Jul 25, 2026