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Single-Use Ureteroscope
EUDAMEDClass IIa (EU MDR)
Ref AE-U75Model Single-Use UreteroscopeRef AE-U75LSRRef AE-U84SRef AE-U75LRRef AE-U75SRef AE-U75RRef AE-U84LSRRef AE-U75LRef AE-U84LRef AE-U84
Identity
- Trade Name
- Single-Use Ureteroscope EUDAMED
- Device Name
- Single-Use Ureteroscope EUDAMED
- Model / Reference
- Single-Use Ureteroscope EUDAMEDAE-U75 EUDAMEDAE-U75LSR EUDAMEDAE-U84S EUDAMEDAE-U75LR EUDAMEDAE-U75S EUDAMEDAE-U75R EUDAMEDAE-U84LSR EUDAMEDAE-U75L EUDAMEDAE-U84L EUDAMEDAE-U84 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942127876912 EUDAMED06942127877292 EUDAMED06942127849015 EUDAMED06942127876998 EUDAMED06942127849008 EUDAMED06942127878602 EUDAMED06942127878657 EUDAMED06942127848988 EUDAMED06942127848995 EUDAMED06942127848971 EUDAMED
- Basic UDI-DI
- 697067138FU038G5 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 Ureteroscope by Alton (Shanghai) Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureteroscope, single-use.
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- 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 (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 | 697067138FU038G5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alton (Shanghai) Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000012832
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (10)
- EUDAMED 20f04398-8240-4a9a-ac01-0858fb10f455 61 fields · synced Aug 3, 2026
- EUDAMED f924be64-c9b7-4ecd-95fd-66deffb8f9da 61 fields · synced Jul 8, 2026
- EUDAMED e0ceb1d6-8f58-46af-8a38-c672a72b8f16 61 fields · synced Jul 10, 2026
- EUDAMED b676d969-3e9d-42a8-addf-efa76cf67073 61 fields · synced Jul 14, 2026
- EUDAMED be5de3fe-66c9-48ed-a9a2-bfe5afe55045 61 fields · synced Jul 18, 2026
- EUDAMED 6f86b4c1-63c8-4e5b-9e03-5896c58621e1 61 fields · synced Jul 21, 2026
- EUDAMED 3a5c99de-b9ad-4b56-bf83-3bd2dcef8dbc 61 fields · synced Jul 23, 2026
- EUDAMED ed778dce-1ee4-448d-842b-7ab8ee908c8d 61 fields · synced Jul 26, 2026
- EUDAMED dddd2a59-25c3-4944-bd97-01ea78e847fa 61 fields · synced Jul 29, 2026
- EUDAMED 84e0ad78-fd15-42d5-aa17-906c1abcf990 61 fields · synced Aug 3, 2026