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Silicone Supra-Pubic Catheter
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 4880-0216Ref 4880-0212Ref 4890-0224Ref A4880-0212Ref A4880-0216Ref 4890-0214Ref 4890-0216Ref 1890-0214Ref 1890-8214Ref 4890-0222Ref 1890-8212Ref 4890-0220
Identity
- Trade Name
- Silicone Supra-Pubic Catheter EUDAMEDSilicone Supra-Pubic Catheter (Integrated Balloon) FDA UDISilicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) FDA UDI
- Generic Name
- Suprapubic drainage catheter FDA UDI
- Device Name
- 4880-0216 EUDAMEDSilicone Supra-Pubic Catheter EUDAMED
- Model / Reference
- 4880-0216 EUDAMED4880-0212 EUDAMED4890-0224 EUDAMEDFDA UDIA4880-0212 EUDAMEDA4880-0216 EUDAMED4890-0214 EUDAMEDFDA UDI4890-0216 EUDAMED1890-0214 EUDAMED4890-0222 EUDAMEDFDA UDI1890-8214 EUDAMEDFDA UDI1890-8212 EUDAMED4890-0220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182612702 EUDAMED04711182612726 EUDAMED14710961937606 EUDAMED14711182612723 EUDAMED14711182612709 EUDAMED04710961937555 EUDAMEDFDA UDI14710961937569 EUDAMED14710961934131 EUDAMED04710961937593 EUDAMEDFDA UDI04710961934202 EUDAMEDFDA UDI04710961937609 EUDAMEDFDA UDI14710961937590 EUDAMED14710961934193 EUDAMED14710961937583 EUDAMED14710961934209 EUDAMED
- Basic UDI-DI
- B-04711182612702 EUDAMEDB-04711182612726 EUDAMEDB-14710961937606 EUDAMEDB-14711182612723 EUDAMEDB-14711182612709 EUDAMEDB-04710961937555 EUDAMEDB-14710961937569 EUDAMEDB-14710961934131 EUDAMEDB-04710961934202 EUDAMEDB-04710961937593 EUDAMEDB-04710961937609 EUDAMEDB-14710961937590 EUDAMEDB-14710961934193 EUDAMEDB-14710961937583 EUDAMEDB-14710961934209 EUDAMED
- 510(k) Number
- K014002 FDA UDI
- FDA Product Code
- KOB FDA UDI
- EMDN Code
- U040199 DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER EUDAMEDU040102 KITS WITH DRAINAGE CATHETERS AND INTRODUCERS 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
- Denmark EUDAMEDBelgium EUDAMEDFinland 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-04711182612702 | 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 (19)
- EUDAMED b2c02cc3-8d00-4402-a1db-3f22331cba3a 61 fields · synced Jul 25, 2026
- EUDAMED 40d866ea-0ce4-425b-9f82-7800f7fd7d36 61 fields · synced May 16, 2026
- EUDAMED e3ecc359-0f86-4736-b205-98dfb2240727 61 fields · synced May 17, 2026
- EUDAMED dd62b7f9-59a0-497a-989e-41f94e3f3111 61 fields · synced May 18, 2026
- EUDAMED 8dc111d6-cebe-494d-b7d6-2ee5e4b90f3b 61 fields · synced May 18, 2026
- EUDAMED 422ddc05-a8a3-4b22-99b0-5fa5c1922d0d 61 fields · synced May 18, 2026
- EUDAMED 75e0a5fe-89d6-4679-becf-428a9b38414a 61 fields · synced May 18, 2026
- EUDAMED f263ced0-1862-44b2-9c47-cdca4a4ba286 61 fields · synced May 18, 2026
- FDA UDI 79e638d9-4a9f-473c-af3c-bee79295d286 33 fields · synced May 29, 2026
- FDA UDI 8861e0af-bcbc-47d7-b7f4-e3d5b7e85a7e 33 fields · synced May 29, 2026
- FDA UDI 2656e076-4ebb-4865-a3d4-0efa21e5a19b 33 fields · synced May 30, 2026
- FDA UDI 29cd78f3-94c8-43a9-9d67-3f4293d09cae 33 fields · synced May 30, 2026
- EUDAMED c6486b1f-a1c0-4f99-b692-07643f168682 61 fields · synced Jul 8, 2026
- EUDAMED fd30d585-a495-4bec-b322-3f6290b747c6 61 fields · synced Jul 8, 2026
- EUDAMED 667eb22d-7995-4262-925d-6ab616444139 61 fields · synced Jul 10, 2026
- EUDAMED 19f58423-d2f5-40ab-9d0d-8a81c26193de 61 fields · synced Jul 14, 2026
- EUDAMED 3f68c7d7-0344-4328-a370-435110f721d2 61 fields · synced Jul 18, 2026
- EUDAMED a6f8dc72-d922-42dd-bcfb-570d94ee85ca 61 fields · synced Jul 24, 2026
- EUDAMED daa16350-d821-4206-9b80-b2f0e642cd5a 61 fields · synced Jul 25, 2026