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Single Use Digital Flexible Ureteroscope (7.5F)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref HUS-T102SRef HUS-T101S
Identity
- Trade Name
- Single Use Digital Flexible Ureteroscope (7.5F) EUDAMED
- Device Name
- Digital Flexible Ureteroscope EUDAMED
- Model / Reference
- HUS-T102S EUDAMEDHUS-T101S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972498492374 EUDAMED06972498492367 EUDAMED
- Basic UDI-DI
- 6972498490100F5 EUDAMED
- Direct Marketing DI
- 06972498492374 EUDAMED06972498492367 EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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 (7.5F) by Anhui Happiness Workshop Medical Instruments Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA…
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 | K252929 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6972498490100F5 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000007232
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 941a1f49-d75d-41bd-83c8-ea6c280e8ecf 61 fields · synced Jul 15, 2026
- EUDAMED 7388a6db-6443-439c-bb75-f4c1eaf92267 61 fields · synced May 19, 2026
- FDA 510(k) K252929 1 fields · synced Jun 9, 2026