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Silicone Hematuria Catheter, Couvelaire
EUDAMEDClass IIb (EU MDR)
Ref 1865-0322Ref 1865-0324Ref 1865-0320Ref 1865-0318
Identity
- Trade Name
- Silicone Hematuria Catheter, Couvelaire EUDAMED
- Device Name
- Silicone Hematuria Catheter, Couvelaire EUDAMED
- Model / Reference
- 1865-0322 EUDAMED1865-0324 EUDAMED1865-0320 EUDAMED1865-0318 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14710961933875 EUDAMED14710961933882 EUDAMED04710961933861 EUDAMED14710961933868 EUDAMED04710961933885 EUDAMED04710961933854 EUDAMED
- Basic UDI-DI
- B-14710961933875 EUDAMEDB-14710961933882 EUDAMEDB-04710961933861 EUDAMEDB-14710961933868 EUDAMEDB-04710961933885 EUDAMEDB-04710961933854 EUDAMED
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Finland EUDAMEDFrance EUDAMEDPoland 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, Couvelaire 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-14710961933875 | 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 (6)
- EUDAMED 5308f363-bc98-4e5d-bb81-6ca96b2f4cea 61 fields · synced Jul 27, 2026
- EUDAMED b9f3c4bd-8a83-46ba-be77-0eca70221946 61 fields · synced May 16, 2026
- EUDAMED 25a63068-6fba-4276-bbcd-8aa16c3f83ea 61 fields · synced May 16, 2026
- EUDAMED 4b56413c-99bc-400d-a461-8deaea2398d7 61 fields · synced May 17, 2026
- EUDAMED aabe9c50-0445-4bdc-9051-64896aa2100c 61 fields · synced May 17, 2026
- EUDAMED e026351b-f95e-44c6-b3fd-97a1ee126768 61 fields · synced May 17, 2026