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Sterile Ureteral Dilation Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref UC04060075
Identity
- Device Name
- Sterile Ureteral Dilation Balloon Catheter EUDAMED
- Model / Reference
- UC04060075 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942033966912 EUDAMED
- Basic UDI-DI
- 69509009CEUDBP7 EUDAMED
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER 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
Sterile Ureteral Dilation Balloon Catheter by Shanghai INT 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 | 69509009CEUDBP7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai INT Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000009966
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 295e5fd3-1ce4-448e-8950-127773eae579 61 fields · synced Aug 3, 2026