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Ureteral Access Sheath
EUDAMEDClass IIa (EU MDR)
Ref AF-D1235AModel Ureteral Access SheathRef AF-D1150AS
Identity
- Trade Name
- Ureteral Access Sheath EUDAMED
- Device Name
- Ureteral Access Sheath EUDAMED
- Model / Reference
- Ureteral Access Sheath EUDAMEDAF-D1235A EUDAMEDAF-D1150AS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942127843914 EUDAMED06942127845376 EUDAMED
- Basic UDI-DI
- 697067138US046LT EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Alton (Shanghai) Medical Instruments 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 | 697067138US046LT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alton (Shanghai) Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000012832
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b7204aef-685a-4389-ad23-f894c9fac6aa 61 fields · synced Oct 6, 2026
- EUDAMED c9e17f71-376d-4a83-9b8e-2310600641b3 61 fields · synced Sep 17, 2026