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Single-use Sterile High-pressure Angiographic Syringes and Accessories
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 256759Model Type I : 25/60ml , 50/50ml, 50/100ml, 50/200ml, 60/60ml, 60/100ml, 60/200ml, 65/65ml, 65/115ml, 100/100ml, 100/200ml, 115/115ml, 125/125ml，130/200ml, 200/200ml, 65/200ml.Ref 256760Model Type II: 25/60ml , 50/50ml, 50/100ml, 50/200ml, 60/60ml, 60/100ml, 60/200ml, 65/65ml, 65/115ml, 100/100ml, 100/200ml, 115/115ml, 125/125ml，130/200ml, 200/200ml, 65/200ml.Ref 255557Model Type II : 25ml, 50ml, 60ml, 65ml, 100ml, 115ml, 125ml, 130ml, 140ml, 150ml, 200mlRef 255544Model Type I : 25ml, 50ml, 60ml, 65ml, 100ml, 115ml, 125ml, 130ml, 140ml, 150ml, 200mlRef 255554Ref 100205ARef 400101RRef 100205Ref 700105Ref DRS-BCD200SRef DRT-SK501FCRef 100113DRef 100119CRef DRS-BMD100Ref 100103GRef 100110DRef 100120PRef 100112
Identity
- Trade Name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories EUDAMED
- Device Name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories EUDAMED
- Model / Reference
- Type I : 25/60ml , 50/50ml, 50/100ml, 50/200ml, 60/60ml, 60/100ml, 60/200ml, 65/65ml, 65/115ml, 100/100ml, 100/200ml, 115/115ml, 125/125ml，130/200ml, 200/200ml, 65/200ml. EUDAMED256759 EUDAMEDType II: 25/60ml , 50/50ml, 50/100ml, 50/200ml, 60/60ml, 60/100ml, 60/200ml, 65/65ml, 65/115ml, 100/100ml, 100/200ml, 115/115ml, 125/125ml，130/200ml, 200/200ml, 65/200ml. EUDAMED256760 EUDAMEDType II : 25ml, 50ml, 60ml, 65ml, 100ml, 115ml, 125ml, 130ml, 140ml, 150ml, 200ml EUDAMED255557 EUDAMEDType I : 25ml, 50ml, 60ml, 65ml, 100ml, 115ml, 125ml, 130ml, 140ml, 150ml, 200ml EUDAMED255544 EUDAMED255554 EUDAMED100205A EUDAMED400101R EUDAMED100205 EUDAMED700105 EUDAMEDDRS-BCD200S EUDAMEDDRT-SK501FC EUDAMED100113D EUDAMED100119C EUDAMEDDRS-BMD100 EUDAMED100103G EUDAMED100110D EUDAMED100120P EUDAMED100112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938327906436 EUDAMED06938327906450 EUDAMED06938327906412 EUDAMED06938327906375 EUDAMED06938327906382 EUDAMED06938327925529 EUDAMED06938327921057 EUDAMED06938327925512 EUDAMED06938327921880 EUDAMED06938327901936 EUDAMED06938327901998 EUDAMED06938327924713 EUDAMED06938327925109 EUDAMED06938327901950 EUDAMED06938327924164 EUDAMED06938327923976 EUDAMED06938327925178 EUDAMED06938327924614 EUDAMED
- Basic UDI-DI
- 69383279205XH EUDAMED69383279206XK EUDAMED69383279204XF EUDAMED69383279203XD EUDAMED
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Angiography kit
Single-use Sterile High-pressure Angiographic Syringes and Accessories by Shenzhen Boon Medical Supply Co., Ltd. — Class IIa — FDA_510K, MDR — listed in…
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241109 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69383279205XH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Boon Medical Supply Co., Ltd.
- EUDAMED SRN
- CN-MF-000018400
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (19)
- EUDAMED b8b14c3f-8fbc-4a9b-88ef-2ed7e09c2bd5 61 fields · synced Oct 6, 2026
- EUDAMED c491bd0a-f4c2-44ac-be60-1974817674f5 61 fields · synced May 16, 2026
- EUDAMED d87338c3-12aa-46c8-9c1f-ca013fc29298 61 fields · synced May 16, 2026
- EUDAMED b0d87434-bb90-488a-8518-72f67c4bad53 61 fields · synced May 17, 2026
- EUDAMED a2ad1c77-9e41-4ad1-854e-73ab2c876cb5 61 fields · synced May 18, 2026
- EUDAMED 50c62a3c-b0b1-4859-9a43-4620106ee9f1 61 fields · synced Jun 20, 2026
- EUDAMED efafcd50-fb0a-4497-9cca-40fd1be15e3f 61 fields · synced Jul 9, 2026
- EUDAMED 8e8a3e83-6324-43af-9458-211438adbb63 61 fields · synced Jul 10, 2026
- EUDAMED 514ccd41-66fc-44a7-924a-c06ee3a77375 61 fields · synced Jul 10, 2026
- EUDAMED 631f56a9-5344-4660-9bc5-5d03c4b4ddf3 61 fields · synced Jul 10, 2026
- EUDAMED ad1ea4d3-bf68-4493-9e9c-1ff9a96964cc 61 fields · synced Jul 13, 2026
- EUDAMED b818f2fa-fc61-4976-a33c-c342eb48ba53 61 fields · synced Jul 13, 2026
- EUDAMED 1b294153-cd18-4bc8-b1cb-a5e7de9925be 61 fields · synced Jul 14, 2026
- EUDAMED 20f8586a-01dd-42ef-9852-94b208b62231 61 fields · synced Jul 19, 2026
- EUDAMED 3efffbb3-2427-496f-baf6-d0c0dd37d99e 61 fields · synced Jul 28, 2026
- EUDAMED f92f46fd-2d7f-42b4-b72e-1d896d1c78c6 61 fields · synced Jul 29, 2026
- EUDAMED d651ee41-cc1f-48c0-8ffd-88995c546eb6 61 fields · synced Jul 29, 2026
- EUDAMED d6df1c15-8e1d-4d8f-bf54-443b6775f1fa 61 fields · synced Jul 30, 2026
- FDA 510(k) K241109 1 fields · synced May 18, 2026