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Single-use Sterile High-pressure Angiographic Syringes and Accessories
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 247238Model 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.
Identity
- Trade Name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories EUDAMEDGuerbet FDA UDI
- Generic Name
- Angiography kit FDA UDI
- Device Name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories EUDAMEDOPTIS SU 2XSYR60ML Y-COIL150CM S X50 Optistar Elite®Dual MR syringe with Single Check Valve Y Tubing (90"/2300mm) and filling spikes - 60mL FDA UDI
- Model / Reference
- 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. EUDAMED247238 EUDAMED200103-AF FDA UDI
- Description
- OPTIS SU 2XSYR60ML Y-COIL150CM S X50 Optistar Elite®Dual MR syringe with Single Check Valve Y Tubing (90"/2300mm) and filling spikes - 60mL FDA UDI
Identifiers
- Catalog Number
- 247238 FDA UDI
- Primary DI / UDI-DI
- 06938327906191 EUDAMEDFDA UDI
- Basic UDI-DI
- 69383279206XK EUDAMED
- Direct Marketing DI
- 06938327906191 EUDAMED
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
- GMDN Term
- Angiography kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- France 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
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
Prescription Use
Yes
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
Category: Angiography kit
Single-use Sterile High-pressure Angiographic Syringes and Accessories by Shenzhen Boon Medical Supply Co., Ltd. — Class IIa — MDR, FDA UDI — listed in…
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69383279206XK | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 706e57d0-3b5f-466c-a31a-62d27b638765 61 fields · synced Jun 18, 2026
- FDA UDI 19c530ee-e4cc-439e-a774-62e4f44a9129 36 fields · synced May 30, 2026