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Renal Dilator Set
EUDAMEDClass IIa (EU MDR)
Ref ZSR-RD01-QG22Model 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-QG22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936345102397 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 |
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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 3429c883-34a2-4439-82b9-0a8390cfbc77 61 fields · synced Jun 19, 2026