Identity
- Trade Name
- Disposable Biopsy Valves EUDAMEDDisposable Biopsy Valve FDA UDI
- Generic Name
- Endoscopic biopsy valve, sterile FDA UDI
- Device Name
- Disposable Biopsy Valves EUDAMED
- Model / Reference
- MD-A-BV01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970401812585 EUDAMEDFDA UDI
- Basic UDI-DI
- 697040181ValveAEOHB EUDAMED
- 510(k) Number
- K173758 FDA UDI
- FDA Product Code
- OCX FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Endoscopic biopsy valve, sterile FDA UDI
Classification
- Device Class
- Class I 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
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
No
Category: Tissue morcellation system handpiece, line-powered
Disposable Biopsy Valves by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Tissue morcellation system handpiece, line-powered.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697040181ValveAEOHB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 444bcd38-66b9-4c5e-b68f-3006740a553d 61 fields · synced Jul 17, 2026
- FDA UDI 2a9e9429-0261-47f1-ae44-05cfc00de998 33 fields · synced May 30, 2026