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Sterile High-pressure Angiographic Syringes for Single-use

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref HT-L2001CFModel 80 InchRef HT-LY1501FModel 60 InchRef HT-LY2502FModel 96 InchRef HT-L1801FModel 72 InchRef HT-LY1501CFRef HT-L1802FRef HT-L201FModel 8 InchRef HT-TS1500FModel 1500 mmRef HT-LT2501FRef HT-TS2000FModel 750 mmRef HT-LY2502CFRef HT-LT1801CFRef 128-400101Model 200 mLRef HT-L1501CFRef HT-L1500FRef HT-LY1801FRef 97-HS-DC201Ref HT-TS2500FRef HT-L201RFRef HT-LY202FModel 200 mmRef HT-L1501FRef 400302DModel 100/100 mLRef 10-1309Ref B103-DCT-STModel 200/200 mLRef 100302Model 65/115 mLRef 400108Ref 200301Model 60/60 mLRef ST-1309YRef B109-DCT-SP

by Shenzhen Boon Medical Supply Co., Ltd.

Identity

Trade Name
Sterile High-pressure Angiographic Syringes for Single-use EUDAMED
Medical Imaging Solutions International FDA UDI
MED-RX FDA UDI
Steriatrics FDA UDI
Genus FDA UDI
Generic Name
Angiography kit FDA UDI
Radiographic procedure tubing FDA UDI
Device Name
Sterile High-pressure Angiographic Syringes for Single-use Accessory EUDAMED
Sterile High-pressure Angiographic Syringes for Single-use EUDAMED
1-150ml Syringe 1-Fill Straw FDA UDI
1-60"(1500mm) Coiled Tubing with Check Valve(DEHP-free) FDA UDI
1-200 mL Syringe 1-Large Spike 1-72” Coiled Tubing FDA UDI
2-60ml Syringes 1-Large Spike & 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI
2-65 mL Syringes 1-Large Spike, 1-Small Spike 1-96" T Coiled Tubing with Check Valve FDA UDI
2-100ml Syringes 1-Large Spike & 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI
1-200ml Syringe 1-Fill Straw 1-60" Coiled Tubing FDA UDI
1-200ml Syringe 1-Large Spike 1-60" Y Coiled Tubing with Dual Check Valves FDA UDI
1-200 mL Syringe 1-Large Spike 1-60” Coiled Tubing FDA UDI
1-60" Y Coiled Tubing with Check Valve FDA UDI
1-60ml Syringes 1-Large Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI
1-200 mL Syringe 1- Large Spike 1-60” Coiled Tubing" FDA UDI
1-65 mL & 1-115 ml Syringes 1-Large Spike, 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI
1-21'' Transfer Set with Swabbable Valve and Ball Check Valve Spike (DEHP-free) FDA UDI
1-200 mL Syringe 1- fill straw 1-60” Coiled Tubing FDA UDI
2-200ml Syringes 2-Fill Straws 1-60" Y Coiled Tubing with Dual Check Valves FDA UDI
2-200ml Syringes 2-Fill Straws 1-60" Y Coiled Tubing with Dual Check Valves FDA UDI
1-J tube FDA UDI
2-200ml Syringes 2-Large Spikes 1-60" Y Coiled Tubing with Dual Check Valves FDA UDI
1-60"(1500mm) Y Coiled Tubing with Dual Check Valves(DEHP-free) FDA UDI
2-60ml Syringes 1-Large Spike & 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI
Model / Reference
80 Inch EUDAMED
HT-L2001CF EUDAMED
60 Inch EUDAMED
HT-LY1501F EUDAMED
96 Inch EUDAMED
HT-LY2502F EUDAMED
72 Inch EUDAMED
HT-L1801F EUDAMED
HT-LY1501CF EUDAMED
HT-L1802F EUDAMED
8 Inch EUDAMED
HT-L201F EUDAMED
1500 mm EUDAMED
HT-TS1500F EUDAMED
HT-LT2501F EUDAMED
750 mm EUDAMED
HT-TS2000F EUDAMED
HT-LY2502CF EUDAMED
HT-LT1801CF EUDAMED
200 mL EUDAMED
128-400101 EUDAMED
HT-L1501CF EUDAMED
HT-L1500F EUDAMED
HT-LY1801F EUDAMED
97-HS-DC201 EUDAMED
HT-TS2500F EUDAMED
HT-L201RF EUDAMED
200 mm EUDAMED
HT-LY202F EUDAMED
HT-L1501F EUDAMED
100/100 mL EUDAMED
400302D EUDAMED
10-1309 EUDAMED
200/200 mL EUDAMED
B103-DCT-ST EUDAMED
65/115 mL EUDAMED
100302 EUDAMED
400108 EUDAMED
60/60 mL EUDAMED
200301 EUDAMED
ST-1309Y EUDAMED
B109-DCT-SP EUDAMED
100201 FDA UDI
400201-4 FDA UDI
100111-B FDA UDI
200103-A FDA UDI
200101-B FDA UDI
100104-B FDA UDI
200107-A FDA UDI
100111-A FDA UDI
100111-C FDA UDI
400102-3 FDA UDI
200103-B FDA UDI
200102-A FDA UDI
700207-2A FDA UDI
100121-A FDA UDI
100114-A FDA UDI
700103 FDA UDI
100121-B FDA UDI
400202-10 FDA UDI
Description
1-150ml Syringe 1-Fill Straw FDA UDI
1-60"(1500mm) Coiled Tubing with Check Valve(DEHP-free) FDA UDI
1-200 mL Syringe 1-Large Spike 1-72” Coiled Tubing FDA UDI
2-60ml Syringes 1-Large Spike & 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI
2-65 mL Syringes 1-Large Spike, 1-Small Spike 1-96" T Coiled Tubing with Check Valve FDA UDI
2-100ml Syringes 1-Large Spike & 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI
1-200ml Syringe 1-Fill Straw 1-60" Coiled Tubing FDA UDI
1-200ml Syringe 1-Large Spike 1-60" Y Coiled Tubing with Dual Check Valves FDA UDI
1-200 mL Syringe 1-Large Spike 1-60” Coiled Tubing FDA UDI
1-60" Y Coiled Tubing with Check Valve FDA UDI
1-60ml Syringes 1-Large Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI
1-200 mL Syringe 1- Large Spike 1-60” Coiled Tubing" FDA UDI
1-65 mL & 1-115 ml Syringes 1-Large Spike, 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI
1-21'' Transfer Set with Swabbable Valve and Ball Check Valve Spike (DEHP-free) FDA UDI
1-200 mL Syringe 1- fill straw 1-60” Coiled Tubing FDA UDI
2-200ml Syringes 2-Fill Straws 1-60" Y Coiled Tubing with Dual Check Valves FDA UDI
2-200ml Syringes 2-Fill Straws 1-60" Y Coiled Tubing with Dual Check Valves FDA UDI
1-J tube FDA UDI
2-200ml Syringes 2-Large Spikes 1-60" Y Coiled Tubing with Dual Check Valves FDA UDI
1-60"(1500mm) Y Coiled Tubing with Dual Check Valves(DEHP-free) FDA UDI
2-60ml Syringes 1-Large Spike & 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI

Identifiers

Catalog Number
300101 FDA UDI
10-1309 FDA UDI
B108-SCT-SP FDA UDI
200301 FDA UDI
100301T FDA UDI
200108 FDA UDI
400302D FDA UDI
B101-SCT-ST FDA UDI
400101Y FDA UDI
L108-SCT-SP FDA UDI
ST-1309Y FDA UDI
200301A FDA UDI
400108 FDA UDI
100302 FDA UDI
10-1306 FDA UDI
128-400101 FDA UDI
B103-DCT-ST FDA UDI
200107D FDA UDI
700103 FDA UDI
B109-DCT-SP FDA UDI
10-1257 FDA UDI
L301-DMR-SP FDA UDI
Primary DI / UDI-DI
06938327909499 EUDAMED
06938327909529 EUDAMED
06938327909703 EUDAMED
06938327909444 EUDAMED
06938327909536 EUDAMED
06938327909659 EUDAMED
06938327909468 EUDAMED
06938327909727 EUDAMED
06938327909680 EUDAMED
06938327909734 EUDAMED
06938327909697 EUDAMED
06938327909635 EUDAMED
06938327904647 EUDAMEDFDA UDI
06938327909437 EUDAMED
06938327909413 EUDAMED
06938327909567 EUDAMED
06938327901677 EUDAMED
06938327909741 EUDAMED
06938327909475 EUDAMED
06938327909550 EUDAMED
06938327909420 EUDAMED
06938327901332 EUDAMEDFDA UDI
06938327901127 EUDAMEDFDA UDI
06938327901189 EUDAMEDFDA UDI
06938327904517 EUDAMEDFDA UDI
06938327901165 EUDAMEDFDA UDI
06938327901042 EUDAMEDFDA UDI
06938327904128 EUDAMEDFDA UDI
06938327904142 EUDAMEDFDA UDI
06938327901011 FDA UDI
06938327904135 FDA UDI
06938327901035 FDA UDI
06938327901097 FDA UDI
06938327904111 FDA UDI
06938327901202 FDA UDI
06938327904067 FDA UDI
06938327901134 FDA UDI
06938327901363 FDA UDI
06938327901080 FDA UDI
06938327901318 FDA UDI
06938327901325 FDA UDI
06938327904098 FDA UDI
Basic UDI-DI
B-06938327909499 EUDAMED
B-06938327909529 EUDAMED
B-06938327909703 EUDAMED
B-06938327909444 EUDAMED
B-06938327909536 EUDAMED
B-06938327909659 EUDAMED
B-06938327909468 EUDAMED
B-06938327909727 EUDAMED
B-06938327909680 EUDAMED
B-06938327909734 EUDAMED
B-06938327909697 EUDAMED
B-06938327909635 EUDAMED
B-06938327904647 EUDAMED
B-06938327909437 EUDAMED
B-06938327909413 EUDAMED
B-06938327909567 EUDAMED
B-06938327901677 EUDAMED
B-06938327909741 EUDAMED
B-06938327909475 EUDAMED
B-06938327909550 EUDAMED
B-06938327909420 EUDAMED
B-06938327901189 EUDAMED
B-06938327901332 EUDAMED
B-06938327904128 EUDAMED
B-06938327901042 EUDAMED
B-06938327901165 EUDAMED
B-06938327901127 EUDAMED
B-06938327904517 EUDAMED
B-06938327904142 EUDAMED
510(k) Number
K151960 FDA UDI
K241109 FDA UDI
FDA Product Code
DXT FDA UDI
EMDN Code
A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
GMDN Term
Angiography kit FDA UDI
Radiographic procedure tubing FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class 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

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

Sterile High-pressure Angiographic Syringes for Single-use by Shenzhen Boon Medical Supply Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID

Similar devices

Also classified as Angiography kit.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Boon Medical Supply Co., Ltd.
EUDAMED SRN
CN-MF-000018400
Authorised Representative
Wellkang Ltd XI-AR-000001836

Sources (51)

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  • FDA UDI 402c4057-b324-44a6-8460-c9260dd306eb 37 fields · synced May 25, 2026
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