Identity
- Trade Name
- NephroMax™ EUDAMEDNephroMax FDA UDI
- Generic Name
- Nephrostomy catheter FDA UDI
- Device Name
- NephroMax High Pressure Balloon Nephrostomy Balloon Catheter EUDAMEDHigh Pressure Nephrostomy Balloon Catheter FDA UDI
- Model / Reference
- M0062101400 EUDAMEDFDA UDI
- Description
- High Pressure Nephrostomy Balloon Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729826484 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000531N4 EUDAMED
- FDA Product Code
- LJE FDA UDI
- EMDN Code
- U040203 NEPHROSTOMY CATHETERS EUDAMED
- GMDN Term
- Nephrostomy catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
NephroMax™ by Boston Scientific Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 01915060000000000000531N4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED d0857804-6bcf-46f4-bed4-e1b834fe2b38 61 fields · synced Jun 19, 2026
- FDA UDI f71115b2-904f-4c44-b830-927c45cd95c2 34 fields · synced May 30, 2026