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Disposable Ureteral Access Sheath
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref BY-AS-1025Model BY-AS
Identity
- Device Name
- Disposable Ureteral Access Sheath EUDAMED
- Model / Reference
- BY-AS EUDAMEDBY-AS-1025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972567822279 EUDAMED
- Basic UDI-DI
- 697256782DYQ001RP EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ureteral introduction sheath
Disposable Ureteral Access Sheath by Suzhou Beyo Medical Technology Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Similar devices
Also classified as Ureteral introduction sheath.
- Manawa Access Sheath — ENVASTE LTD · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
- Disposable Ureteral Guide Sheath — Dongguan ZSR Biomedical Technology Company Limited · Class IIa
- Disposable access sheath — Hangzhou Hawk Medical Technology Co., Ltd · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203165 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697256782DYQ001RP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Beyo Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000005660
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED bb64393d-b2ee-484e-ac72-610f5df3f594 61 fields · synced Jun 20, 2026
- FDA 510(k) K203165 1 fields · synced May 18, 2026