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Flexible Ureterorenoscopes
EUDAMEDClass IIa (EU MDR)
Ref US27H-12-EUModel US31D-12-US, US31D-12-EU and etc.
Identity
- Device Name
- Flexible Ureterorenoscopes EUDAMED
- Model / Reference
- US31D-12-US, US31D-12-EU and etc. EUDAMEDUS27H-12-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970034211304 EUDAMED
- Basic UDI-DI
- 697003421USWW EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Flexible Ureterorenoscopes by Shanghai Anqing 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 | 697003421USWW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai Anqing Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000008487
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 06bb26dd-0acc-4331-b2df-0ad0d66db68e 61 fields · synced Jun 20, 2026