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Sclerotherapy Needles

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref MD-B-SY-2412-2108

by Zhejiang Chuangxiang Medical Technology Co., LTD.

Identity

Trade Name
Sclerotherapy Needles EUDAMED
Sclerotherapy needle FDA UDI
Generic Name
General-purpose endoscopic needle, single-use FDA UDI
Device Name
Sclerotherapy Needles EUDAMED
Model / Reference
MD-B-SY-2412-2108 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
06974173021275 EUDAMEDFDA UDI
Basic UDI-DI
697417302SclerotherapyAHN EUDAMED
510(k) Number
K212668 FDA UDI
FDA Product Code
FBK FDA UDI
EMDN Code
G03020101 DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES EUDAMED
GMDN Term
General-purpose endoscopic needle, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Market of Registration
Austria 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

No

FDA UDI

Sclerotherapy Needles are medical devices used for the treatment of vascular lesions and varicose veins. These needles are designed to deliver a solution to the affected area, promoting healing and reducing inflammation. With their precise mechanism of action and user-friendly interface, Sclerotherapy Needles make them an ideal choice for clinicians seeking effective treatments.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zhejiang Chuangxiang Medical Technology Co., LTD.
EUDAMED SRN
CN-MF-000012417
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 4b5b05be-3aa5-4d8d-9975-087f5d3ab26b 61 fields · synced Jul 24, 2026
  • FDA UDI e8469686-cb0f-414d-8247-971a5243f6ca 33 fields · synced May 29, 2026