Pot
Ref 833-3010, 833-2510, 833-2512, 833-2712, 833-5010, 833-5015, 833-4010, 833-3515, 833-2215510(k) K230705
Active
CE MDR CE MDD 510(k)
Valid until
4 Aug 2031
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | NumberMDR.2292-2026/0055 | Date5 Aug 2026 | StatusActive |
| European Union | CE/MDD EUDAMED | NumberB-06958481467147 | Date21 Apr 2025 | StatusActive |
| United States | GUDID listing GUDID | Number06958481467147 | Date8 May 2023 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK230705 | Date11 Apr 2023 | StatusActive |
Certificates
- MDR.2292-2026/0055 Active
Technical documentation EU MDR
- Certifier
- UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
- Issued
- 5 Aug 2026
- Expires
- 4 Aug 2031
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Pot EUDAMEDPOT PTCA Balloon Dilatation Catheter GUDID
- Generic Name
- Coronary angioplasty balloon catheter, basic
- Model / Ref / Catalog
- 833-3010, 833-2510, 833-2512, 833-2712, 833-5010, 833-5015, 833-4010, 833-3515, 833-2215, rev01
- Primary DI / UDI-DI
- 06958481467147 EUDAMED06958481467062 EUDAMED06958481467079 EUDAMED06958481467116 EUDAMED06958481467383 EUDAMED06958481467406 EUDAMED06958481467307 EUDAMED06958481467246 EUDAMED06958481467048 EUDAMED06958481438611 GUDID06958481438451 GUDID06958481438697 GUDID06958481438420 GUDID06958481438352 GUDID06958481438710 GUDID06958481438550 GUDID06958481438376 GUDID06958481438383 GUDID
- Basic UDI-DI
- B-06958481467147, B-06958481467062, B-06958481467079, B-06958481467116, B-06958481467383, B-06958481467406, B-06958481467307, B-06958481467246, B-06958481467048, 695848140007M5
- 510(k) Number
- FDA Product Code
- LOX
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- GMDN Term
- Coronary angioplasty balloon catheter, basic
- Device Class
- Class III EUDAMEDClass II 510(k)GUDID
- Regulation
- 21 CFR Part 870.5100
- EU market of registration
- Netherlands
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | 510(k) | GUDID |
|---|---|---|---|
| Model / Reference | 833-3010 833-2510 833-2512 833-2712 833-5010 833-5015 833-4010 833-3515 833-2215 | — | rev01 |
| Primary DI / UDI-DI | 06958481467147 06958481467062 06958481467079 06958481467116 06958481467383 06958481467406 06958481467307 06958481467246 06958481467048 | — | 06958481438611 06958481438451 06958481438697 06958481438420 06958481438352 06958481438710 06958481438550 06958481438376 06958481438383 |
| Device Class | Class III | Class II | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000007501
- Authorised representative
- Brosmed Medical B.V. NL-AR-000002616
Other devices from BrosMed Medical Co., Ltd.
Properties
Other properties (20)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No