Identity
- Trade Name
- Silicone Hematuria Catheter, Dufour EUDAMED
- Device Name
- Silicone Hematuria Catheter, Dufour EUDAMED
- Model / Reference
- 1864-0320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961933786 EUDAMED
- Basic UDI-DI
- B-04710961933786 EUDAMED
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Silicone Hematuria Catheter, Dufour by Fortune Medical Instrument Corp. — 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-04710961933786 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED a39dfbfd-fe36-4f8b-bd51-a67e6b4efdbf 61 fields · synced Jun 19, 2026