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Single-use Flexible Ureteroscope
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref US-S2602Model Models: US01 series: US-S170, US-S180, US-E170, US-E180, US-S170R, US-E170R; US02 series: US-S2600, USE2600, US-S2600R, US-E2600R, US-S2602, US-E2602, USS2602R, US-E2602R510(k) K250785
Identity
- Device Name
- Single-use Flexible Ureteroscope EUDAMED
- Model / Reference
- Models: US01 series: US-S170, US-S180, US-E170, US-E180, US-S170R, US-E170R; US02 series: US-S2600, USE2600, US-S2600R, US-E2600R, US-S2602, US-E2602, USS2602R, US-E2602R EUDAMEDUS-S2602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972197483956 EUDAMED
- Basic UDI-DI
- 697219748US5Q EUDAMED
- EMDN Code
- Z12020709 UTEROSCOPES 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
Single-use Flexible Ureteroscope by Hunan Vathin Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K230200 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K250785 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697219748US5Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hunan Vathin Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000002593
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED db0b46e4-1a43-4c9c-9a5f-8ec50cc2a65c 85 fields · synced Jun 18, 2026
- FDA 510(k) K230200 1 fields · synced May 18, 2026