← Back to catalogue
Renal Dilator Set
EUDAMEDClass IIa (EU MDR)
Ref ZSR-RD01-KZ18Model ZSR-RD01、ZSR-RD02、ZSR-RD03、ZSR-RD06
Identity
- Trade Name
- Renal Dilator Set EUDAMED
- Device Name
- Renal Dilator Set EUDAMED
- Model / Reference
- ZSR-RD01、ZSR-RD02、ZSR-RD03、ZSR-RD06 EUDAMEDZSR-RD01-KZ18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936345102304 EUDAMED
- Basic UDI-DI
- 69363451ZSRRDS01194 EUDAMED
- EMDN Code
- U03010199 PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Renal Dilator Set 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 | 69363451ZSRRDS01194 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dongguan ZSR Biomedical Technology Company Limited
- EUDAMED SRN
- CN-MF-000016828
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED d92b155b-88d3-4ade-9fff-2331c5f5375b 61 fields · synced Jun 20, 2026