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Silicone Hematuria Catheter, Couvelaire
EUDAMEDClass IIb (EU MDR)
Ref 1865-0322
Identity
- Trade Name
- Silicone Hematuria Catheter, Couvelaire EUDAMED
- Device Name
- Silicone Hematuria Catheter, Couvelaire EUDAMED
- Model / Reference
- 1865-0322 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961933878 EUDAMED
- Basic UDI-DI
- B-04710961933878 EUDAMED
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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-04710961933878 | 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 75d9e9c7-f4f4-49ff-bd24-7b6ff2668ada 61 fields · synced Jun 17, 2026