Identity
- Trade Name
- Silicone Supra-Pubic Catheter EUDAMEDSilicone Supra-Pubic Catheter (Integrated Balloon) FDA UDI
- Generic Name
- Suprapubic drainage catheter FDA UDI
- Device Name
- Silicone Supra-Pubic Catheter EUDAMED
- Model / Reference
- 4890-0220 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710961937586 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04710961937586 EUDAMED
- 510(k) Number
- K014002 FDA UDI
- FDA Product Code
- KOB FDA UDI
- EMDN Code
- U040199 DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER EUDAMED
- GMDN Term
- Suprapubic drainage catheter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5090 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Silicone Supra-Pubic Catheter by Fortune Medical Instrument Corp. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04710961937586 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 (2)
- EUDAMED 69763a60-96d1-4fe7-8f7c-45f14cc712a0 61 fields · synced Jul 15, 2026
- FDA UDI be9fe952-c9c2-426f-8296-24f786c2408f 33 fields · synced May 30, 2026