Identity
- Trade Name
- Sclerotherapy Needles EUDAMEDSclerotherapy needle FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- Sclerotherapy Needles EUDAMEDwithout fixed button FDA UDI
- Model / Reference
- MD-B-SY-2418-2106 EUDAMEDFDA UDI
- Description
- without fixed button FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936534330815 EUDAMEDFDA UDI
- Basic UDI-DI
- 697417302SclerotherapyBHQ 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 EUDAMEDClass 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 by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697417302SclerotherapyBHQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 c60257a1-0015-46cf-9b4a-856f1edb6de2 61 fields · synced Sep 17, 2026
- FDA UDI cabf4236-309b-4a2a-b0b3-cfcd89ea4900 34 fields · synced May 30, 2026