Sterile High-pressure Angiographic Syringes for Single-use
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Sterile High-pressure Angiographic Syringes for Single-use EUDAMEDSinton Medical Products FDA UDI
- Generic Name
- Radiographic procedure tubing FDA UDI
- Device Name
- Sterile High-pressure Angiographic Syringes for Single-use Accessory EUDAMED1-80" (2000mm) Coiled Tubing with Check Valve FDA UDI
- Model / Reference
- 80 Inch EUDAMEDHT-L2001C EUDAMED400101-10 FDA UDI
- Description
- 1-80" (2000mm) Coiled Tubing with Check Valve FDA UDI
Identifiers
- Catalog Number
- HT-L2001C FDA UDI
- Primary DI / UDI-DI
- 06938327902599 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06938327902599 EUDAMED
- 510(k) Number
- K151960 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
- GMDN Term
- Radiographic procedure tubing FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Angiography kit
Sterile High-pressure Angiographic Syringes for Single-use are medical devices designed for vascular procedures, featuring high pressure and precise control. These syringes are used in various healthcare settings, including emergency medicine and surgery, to provide accurate imaging and treatment.
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Also classified as Angiography kit.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06938327902599 | 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 c5d4c36d-8351-4974-be43-5f19436fb778 61 fields · synced Oct 6, 2026
- FDA UDI 56fdd2ae-8792-4f33-b2a5-8233e7f3a02a 37 fields · synced May 27, 2026