Disposable Biopsy Valves
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- Disposable Biopsy Valves EUDAMEDDisposable Biopsy Valve FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- Disposable Biopsy Valves EUDAMEDNon-sterile FDA UDI
- Model / Reference
- MD-B-BV02 EUDAMEDFDA UDI
- Description
- Non-sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970401817146 EUDAMEDFDA UDI
- Basic UDI-DI
- 697040181BiopsyValveMB 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
- Endoscope working-channel valve, single-use 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
No
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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Similar devices
Also classified as Tissue morcellation system handpiece, line-powered.
- Aveta Disposable Resecting Device 2.9 mm — Meditrina, Inc. · Class II
- Disposable Guidewire — Alton (Shanghai) Medical Instruments Co., Ltd. · Class I
- Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit — GA HEALTH COMPANY LIMITED · Class I
- 2-piece Cleaning Adapter + 4-piece Valve Kit — GA HEALTH COMPANY LIMITED · Class IIa
- Guide Wires — Changzhou Health Microport Medical Device Co., Ltd · Class IIa
- Aveta Disposable Resecting Device 3.9 mm — Meditrina, Inc. · Class II
- 3-piece valve kit — GA HEALTH COMPANY LIMITED · Class I
- Disposable Guidewire — Alton (Shanghai) Medical Instruments Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173758 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697040181BiopsyValveMB | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 (3)
- EUDAMED 36494669-0311-4ba0-a571-548b2c5af1b4 61 fields · synced Jul 10, 2026
- FDA UDI 86f51065-b0b9-4cc4-b752-0e61b588c305 34 fields · synced May 30, 2026
- FDA 510(k) K173758 1 fields · synced May 18, 2026