Identity
- Device Name
- Reusable Ureterorenoscope EUDAMED
- Model / Reference
- HU32 EUDAMED8001B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970462540908 EUDAMED
- Basic UDI-DI
- 69704625480018P EUDAMED
- Direct Marketing DI
- 06970462540908 EUDAMED
- EMDN Code
- Z12020709 UTEROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Reusable Ureterorenoscope by Shenzhen HugeMed Medical Technical Development 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 | 69704625480018P | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010895
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8b7cd19a-6dbd-40cd-b3ba-b0f3a12ab0bc 61 fields · synced Jul 26, 2026