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Single-use Flexible Ureteroscope
EUDAMEDClass IIa (EU MDR)
Ref US-S180Model 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-E2602RRef US-S2602RRef US-E2602Ref US-E170Ref US-S170Ref US-E170RRef US-E2602R
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-S180 EUDAMEDUS-S2602R EUDAMEDUS-E2602 EUDAMEDUS-E170 EUDAMEDUS-S170 EUDAMEDUS-E170R EUDAMEDUS-E2602R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972197483932 EUDAMED06972197483970 EUDAMED06972197483963 EUDAMED06972197483567 EUDAMED06972197483543 EUDAMED06972197483574 EUDAMED06972197483987 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
EUDAMEDEUDAMED
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 — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (7)
- EUDAMED 2a84cceb-54af-423b-8ca6-6cd490fabdda 61 fields · synced Sep 17, 2026
- EUDAMED 434c61f5-5695-4686-808d-f344a4b86d6e 61 fields · synced May 17, 2026
- EUDAMED 340e5676-5d08-4784-a443-cac6213dd7cd 61 fields · synced May 17, 2026
- EUDAMED 5e604f19-1d9d-47a1-b44d-1765a921ffe6 61 fields · synced May 18, 2026
- EUDAMED 231b9dfd-ea70-400f-a182-4484f1dd77ce 61 fields · synced May 18, 2026
- EUDAMED 2e6cbb7b-ba58-4af1-bf93-3c692f11cb76 61 fields · synced May 18, 2026
- EUDAMED 0538e9db-e19f-4d59-b46b-50de0f666ebd 61 fields · synced May 18, 2026