Brilliant CS070718
by Lepu Medical Technology (Beijing) Co., Ltd.
Ref RSC071621-NW70, RSC070521-HW45, RSC051618-NS70, RSC061621-SW70-IN20, RSC060518-SW45-IN20, RSC042425-NJ70, RSC051625-NS70, RSC072421-HS70, RSC060518-NJ45, RSC042418-SW70-IN20, RSC040721-SS45-IN20-K-S, RSC040521-NS45-IN20-K-S, RSC062418-NS70-IN20-K-S, RSC052418-NS70, RSC051121-SJ45-IN20, RSC061118-NJ45-IN20, RSC040525-SW45-IN20-K-S, RSC060521-HS45-IC22-K-S, RSC060718-SW45, RSC060521-SJ45-IN20-K-S, RSC071118-SS45, RSC061618-NJ70-IN20, RSC051625, RSC040525-NW45-IN20-K-S, RSC072421-SJ70-IN20-K-S, RSC070521-HW45-IC22-K-S, RSC071618-SS70-IN20, RSC060718-NS45-IN20-K-S, RSC060525-SS45, RSC040721-NJ45-IN20, RSC040518-NW45-IN20, RSC052418-SW70-IN20, RSC042421-NJ70, RSC051125-NJ45-IN20-K-S, RSC041625-SJ70-IN20-K-S, RSC061121-SJ45-IN20, RSC041121-HW45-IC22, RSC070521-NS45-IN20-K-S, RSC040525-SS45-IN20, RSC051121-SW45-IN20, RSC060718-NJ45, RSC070518-NW45-IN20, RSC070521-HS45-IC22-K-S, RSC050725-SW45, RSC040725-NJ45-IN20, RSC041118-SW45-IN20-K-S, RSC062418-NS70-IN20, RSC071118-SJ45-IN20-K-S, RSC060525-SJ45-IN20, RSC042421-HW70Model RSC series, With Nitinol guidewire, RSC series, With Hydrophilic guidewire, RSC series, With stainless steel guidewire, RSC series, no guidewire
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69367337LP0039MZ | Date21 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06941785235369 | Date16 Nov 2018 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Brilliant™ EUDAMEDBrilliant GUDID
- Generic Name
- Vascular catheter introduction set, nonimplantable
- Device Name
- Introducer Kit
- Model / Reference
- RSC series EUDAMEDWith Nitinol guidewire EUDAMEDRSC071621-NW70 EUDAMEDWith Hydrophilic guidewire EUDAMEDRSC070521-HW45 EUDAMEDRSC051618-NS70 EUDAMEDWith stainless steel guidewire EUDAMEDRSC061621-SW70-IN20 EUDAMEDRSC060518-SW45-IN20 EUDAMEDRSC042425-NJ70 EUDAMEDRSC051625-NS70 EUDAMEDRSC072421-HS70 EUDAMEDRSC060518-NJ45 EUDAMEDRSC042418-SW70-IN20 EUDAMEDRSC040721-SS45-IN20-K-S EUDAMEDRSC040521-NS45-IN20-K-S EUDAMEDRSC062418-NS70-IN20-K-S EUDAMEDRSC052418-NS70 EUDAMEDRSC051121-SJ45-IN20 EUDAMEDRSC061118-NJ45-IN20 EUDAMEDRSC040525-SW45-IN20-K-S EUDAMEDRSC060521-HS45-IC22-K-S EUDAMEDRSC060718-SW45 EUDAMEDRSC060521-SJ45-IN20-K-S EUDAMEDRSC071118-SS45 EUDAMEDRSC061618-NJ70-IN20 EUDAMEDno guidewire EUDAMEDRSC051625 EUDAMEDRSC040525-NW45-IN20-K-S EUDAMEDRSC072421-SJ70-IN20-K-S EUDAMEDRSC070521-HW45-IC22-K-S EUDAMEDRSC071618-SS70-IN20 EUDAMEDRSC060718-NS45-IN20-K-S EUDAMEDRSC060525-SS45 EUDAMEDRSC040721-NJ45-IN20 EUDAMEDRSC040518-NW45-IN20 EUDAMEDRSC052418-SW70-IN20 EUDAMEDRSC042421-NJ70 EUDAMEDRSC051125-NJ45-IN20-K-S EUDAMEDRSC041625-SJ70-IN20-K-S EUDAMEDRSC061121-SJ45-IN20 EUDAMEDRSC041121-HW45-IC22 EUDAMEDRSC070521-NS45-IN20-K-S EUDAMEDRSC040525-SS45-IN20 EUDAMEDRSC051121-SW45-IN20 EUDAMEDRSC060718-NJ45 EUDAMEDRSC070518-NW45-IN20 EUDAMEDRSC070521-HS45-IC22-K-S EUDAMEDRSC050725-SW45 EUDAMEDRSC040725-NJ45-IN20 EUDAMEDRSC041118-SW45-IN20-K-S EUDAMEDRSC062418-NS70-IN20 EUDAMEDRSC071118-SJ45-IN20-K-S EUDAMEDRSC060525-SJ45-IN20 EUDAMEDRSC042421-HW70 EUDAMEDCS070718 GUDID
- Primary DI / UDI-DI
- 06941785235369 EUDAMED06941785230357 EUDAMED06941785234751 EUDAMED06941785234102 EUDAMED06941785225810 EUDAMED06941785234980 EUDAMED06941785234775 EUDAMED06941785236991 EUDAMED06941785227258 EUDAMED06941785234003 EUDAMED06936733730942 EUDAMED06941785228880 EUDAMED06941785236281 EUDAMED06941785234782 EUDAMED06941785225438 EUDAMED06941785228392 EUDAMED06941785226374 EUDAMED06936733738900 EUDAMED06941785224837 EUDAMED06941785226183 EUDAMED06941785224233 EUDAMED06941785235772 EUDAMED06936733711057 EUDAMED06941785229610 EUDAMED06941785234430 EUDAMED06941785230920 EUDAMED06941785233679 EUDAMED06941785229085 EUDAMED06941785224103 EUDAMED06941785228194 EUDAMED06941785228514 EUDAMED06941785234065 EUDAMED06941785234973 EUDAMED06941785229405 EUDAMED06941785234232 EUDAMED06941785225520 EUDAMED06941785230593 EUDAMED06941785229153 EUDAMED06941785225001 EUDAMED06941785225797 EUDAMED06941785227289 EUDAMED06941785228781 EUDAMED06936733738931 EUDAMED06941785224769 EUDAMED06941785228200 EUDAMED06941785226411 EUDAMED06941785235567 EUDAMED06941785226329 EUDAMED06941785225476 EUDAMED06941785237035 EUDAMED06936733738047 GUDID
- Basic UDI-DI
- 69367337LP0039MZ, 69367337LP0040MJ, 69367337LP0038MX, 69367337LP0037MV
- FDA Product Code
- DYB
- EMDN Code
- C01040280 Peripheral angiography devices - accessories not included in other classes
- GMDN Term
- Vascular catheter introduction set, nonimplantable
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 870.1340
- Market of Registration
- Cyprus
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | RSC series, With Nitinol guidewire RSC071621-NW70 RSC series, With Hydrophilic guidewire RSC070521-HW45 RSC051618-NS70 RSC series, With stainless steel guidewire RSC061621-SW70-IN20 RSC060518-SW45-IN20 RSC042425-NJ70 RSC051625-NS70 RSC072421-HS70 RSC060518-NJ45 RSC042418-SW70-IN20 RSC040721-SS45-IN20-K-S RSC040521-NS45-IN20-K-S RSC062418-NS70-IN20-K-S RSC052418-NS70 RSC051121-SJ45-IN20 RSC061118-NJ45-IN20 RSC040525-SW45-IN20-K-S RSC060521-HS45-IC22-K-S RSC060718-SW45 RSC060521-SJ45-IN20-K-S RSC071118-SS45 RSC061618-NJ70-IN20 RSC series, no guidewire RSC051625 RSC040525-NW45-IN20-K-S RSC072421-SJ70-IN20-K-S RSC070521-HW45-IC22-K-S RSC071618-SS70-IN20 RSC060718-NS45-IN20-K-S RSC060525-SS45 RSC040721-NJ45-IN20 RSC040518-NW45-IN20 RSC052418-SW70-IN20 RSC042421-NJ70 RSC051125-NJ45-IN20-K-S RSC041625-SJ70-IN20-K-S RSC061121-SJ45-IN20 RSC041121-HW45-IC22 RSC070521-NS45-IN20-K-S RSC040525-SS45-IN20 RSC051121-SW45-IN20 RSC060718-NJ45 RSC070518-NW45-IN20 RSC070521-HS45-IC22-K-S RSC050725-SW45 RSC040725-NJ45-IN20 RSC041118-SW45-IN20-K-S RSC062418-NS70-IN20 RSC071118-SJ45-IN20-K-S RSC060525-SJ45-IN20 RSC042421-HW70 | CS070718 |
| Primary DI / UDI-DI | 06941785235369 06941785230357 06941785234751 06941785234102 06941785225810 06941785234980 06941785234775 06941785236991 06941785227258 06941785234003 06936733730942 06941785228880 06941785236281 06941785234782 06941785225438 06941785228392 06941785226374 06936733738900 06941785224837 06941785226183 06941785224233 06941785235772 06936733711057 06941785229610 06941785234430 06941785230920 06941785233679 06941785229085 06941785224103 06941785228194 06941785228514 06941785234065 06941785234973 06941785229405 06941785234232 06941785225520 06941785230593 06941785229153 06941785225001 06941785225797 06941785227289 06941785228781 06936733738931 06941785224769 06941785228200 06941785226411 06941785235567 06941785226329 06941785225476 06941785237035 | 06936733738047 |
| Device Class | Class IIa | Class II |
Other devices from Lepu Medical Technology (Beijing) Co., Ltd.
See all devices from Lepu Medical Technology (Beijing) Co., Ltd. →
Properties
Other properties (19)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No