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Single-Use Digital Flexible Ureteroscope
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref ZSR-URS-01Model ZSR-URS-01、ZSR-URS-02、ZSR-URS-03、ZSR-URS-04
Identity
- Trade Name
- Single-Use Digital Flexible Ureteroscope EUDAMED
- Device Name
- Single-Use Digital Flexible Ureteroscope EUDAMED
- Model / Reference
- ZSR-URS-01、ZSR-URS-02、ZSR-URS-03、ZSR-URS-04 EUDAMEDZSR-URS-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936345105749 EUDAMED
- Basic UDI-DI
- 69363451ZSRURS012F7 EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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: Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope by Dongguan ZSR Biomedical Technology Company Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- Ureterorenoscope — Innoview GmbH · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
- URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
- CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
- LithoVue — Boston Scientific · Class II
- Single-use Digital Flexible Ureterorenoscopes — NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa
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 | K243155 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69363451ZSRURS012F7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dongguan ZSR Biomedical Technology Company Limited
- EUDAMED SRN
- CN-MF-000016828
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED c5383ae2-f32d-4f11-aec7-816a27b21204 61 fields · synced Oct 6, 2026
- FDA 510(k) K243155 1 fields · synced May 18, 2026