← Back to catalogue

Sterile High-pressure Angiographic Syringes for Single-use

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 239947B

by Shenzhen Boon Medical Supply Co., Ltd.

Identity

Trade Name
Sterile High-pressure Angiographic Syringes for Single-use EUDAMED
LF FDA UDI
Generic Name
Radiographic procedure tubing FDA UDI
Device Name
Sterile High-pressure Angiographic Syringes for Single-use Accessory EUDAMED
8"(200 mm) Patient line with single valve for CT and MRI(DEHP FREE) FDA UDI
Model / Reference
239947B EUDAMED
400201-7 FDA UDI
Description
8"(200 mm) Patient line with single valve for CT and MRI(DEHP FREE) FDA UDI

Identifiers

Catalog Number
239947B FDA UDI
Primary DI / UDI-DI
06938327906269 EUDAMEDFDA UDI
Basic UDI-DI
B-06938327906269 EUDAMED
510(k) Number
K182289 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 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 (2)

  • EUDAMED 51497c6a-d967-40a7-a3fd-a6e4b3469271 61 fields · synced Jul 31, 2026
  • FDA UDI 94b00fc7-299c-4242-ae8f-2f3c77fb27e2 37 fields · synced May 30, 2026