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Single-use Ureteral Access Sheath
EUDAMEDClass IIa (EU MDR)
Ref UA-1125Model UA-（1025、1035、1045、1125、1135、1145、1225、1235、1245、1325、1335、1345、1425、1435、1445）
Identity
- Trade Name
- Single-use Ureteral Access Sheath EUDAMED
- Device Name
- Single-use Ureteral Access Sheath EUDAMED
- Model / Reference
- UA-（1025、1035、1045、1125、1135、1145、1225、1235、1245、1325、1335、1345、1425、1435、1445） EUDAMEDUA-1125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381257298 EUDAMED
- Basic UDI-DI
- 697138125021A89 EUDAMED
- Direct Marketing DI
- 06971381257298 EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
Single-use Ureteral Access Sheath by Scivita Medical Technology 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 | 697138125021A89 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 79cd62a8-8e67-44fb-9717-8548131d0c78 61 fields · synced Jun 19, 2026