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Disposable Ureteral Guide Sheath
EUDAMEDClass IIa (EU MDR)
Ref ZSR-UAC-1145AModel ZSR-UA, ZSR-UAY, ZSR-UAW
Identity
- Trade Name
- Disposable Ureteral Guide Sheath EUDAMED
- Device Name
- Disposable Ureteral Guide Sheath EUDAMED
- Model / Reference
- ZSR-UA, ZSR-UAY, ZSR-UAW EUDAMEDZSR-UAC-1145A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936345109624 EUDAMED
- Basic UDI-DI
- 69363451ZSRUGS007BM EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS 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
Disposable Ureteral Guide Sheath by Dongguan ZSR Biomedical Technology Company Limited — 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 | 69363451ZSRUGS007BM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dongguan ZSR Biomedical Technology Company Limited
- EUDAMED SRN
- CN-MF-000016828
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 11ae01e4-b510-4af3-a7db-58cb22fa9255 61 fields · synced Jun 18, 2026