Identity
- Device Name
- Nephroscopes EUDAMED
- Model / Reference
- SN-IV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947014612628 EUDAMED
- Basic UDI-DI
- B-06947014612628 EUDAMED
- EMDN Code
- Z12020705 NEPHROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nephroscopes by Hangzhou Hawk Optical Electronic Instruments Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06947014612628 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000028791
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 593cef3c-ee5d-4026-808e-d4fc23ffb686 61 fields · synced Jun 19, 2026