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Single-Use Ureteroscope
EUDAMEDClass IIa (EU MDR)
Ref AE-U84RModel Single-Use Ureteroscope
Identity
- Trade Name
- Single-Use Ureteroscope EUDAMED
- Device Name
- Single-Use Ureteroscope EUDAMED
- Model / Reference
- Single-Use Ureteroscope EUDAMEDAE-U84R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942127878619 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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- 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 (1)
- EUDAMED 34818387-786a-4a57-aba0-0b119abc86bc 61 fields · synced Jun 19, 2026