Identity
- Trade Name
- Navigator™ EUDAMEDNavigator FDA UDI
- Generic Name
- Endoscopic-access dilator, single-use FDA UDI
- Device Name
- Navigator UAS Family EUDAMEDUreteral Access Sheath Set FDA UDI
- Model / Reference
- M0062502080 EUDAMEDFDA UDI
- Description
- Ureteral Access Sheath Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729429999 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000540N5 EUDAMED
- FDA Product Code
- KOD FDA UDIFED FDA UDI
- EMDN Code
- U0399 DEVICES FOR URINARY TRACT DILATION - OTHER EUDAMED
- GMDN Term
- Endoscopic-access dilator, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI876.1500 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
Navigator™ 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 | 01915060000000000000540N5 | 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 3e779f5b-5287-4eff-a261-28ed70172ba3 61 fields · synced Oct 6, 2026
- FDA UDI 97268562-cbc0-4780-8399-078010d341f7 34 fields · synced May 30, 2026