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Silicone Hematuria Catheter, Dufour
EUDAMEDClass IIb (EU MDR)
Ref 1864-0322Ref 1864-0320Ref 1864-0324Ref 1864-0318
Identity
- Trade Name
- Silicone Hematuria Catheter, Dufour EUDAMED
- Device Name
- Silicone Hematuria Catheter, Dufour EUDAMED
- Model / Reference
- 1864-0322 EUDAMED1864-0320 EUDAMED1864-0324 EUDAMED1864-0318 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961933793 EUDAMED14710961933783 EUDAMED04710961933809 EUDAMED04710961933779 EUDAMED14710961933776 EUDAMED
- Basic UDI-DI
- B-04710961933793 EUDAMEDB-14710961933783 EUDAMEDB-04710961933809 EUDAMEDB-04710961933779 EUDAMEDB-14710961933776 EUDAMED
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMEDBulgaria EUDAMEDPoland EUDAMEDCzechia 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-04710961933793 | 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 (5)
- EUDAMED 9e47d3b4-3988-4b90-a8b1-7a6bd2922058 61 fields · synced Jul 17, 2026
- EUDAMED ebfd9006-5a55-4c95-a1fc-6877872f7199 61 fields · synced May 17, 2026
- EUDAMED d92294b1-a7ea-48a6-a2fd-1e4939f19a0b 61 fields · synced May 17, 2026
- EUDAMED 49e68a09-8e7f-4275-bcac-233d40b78255 61 fields · synced May 17, 2026
- EUDAMED 08f1e1f0-cb00-42cb-8321-64c657540a3c 61 fields · synced May 19, 2026