Identity
- Device Name
- Ureteral Access Sheath EUDAMED
- Model / Reference
- UASU-130-400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941903610801 EUDAMED
- Basic UDI-DI
- 697182106Y0105B9 EUDAMED
- EMDN Code
- U0999 UROGENITAL ENDOSCOPIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Ureteral Access Sheath by MicroPort Urocare (Jiaxing) 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 | 697182106Y0105B9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MicroPort Urocare (Jiaxing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002345
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED 2aa59fa2-e748-4d57-8db3-fc0a96fa9175 61 fields · synced Jun 19, 2026