Identity
- Trade Name
- Dreamtome™ EUDAMEDDreamtome™ RX 49 FDA UDI
- Generic Name
- ERCP catheter, non-balloon, electrosurgical FDA UDI
- Device Name
- Sphincterotome EUDAMEDFDA UDI
- Model / Reference
- M00584010 EUDAMEDFDA UDI
- Description
- Sphincterotome FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729778233 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000521MZ EUDAMED
- FDA Product Code
- KNS FDA UDI
- EMDN Code
- G03040202 PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN EUDAMED
- GMDN Term
- ERCP catheter, non-balloon, electrosurgical FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 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
Yes
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
Dreamtome™ by Boston Scientific Corporation — Class IIb — 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 | 01915060000000000000521MZ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 f1d923d5-9dd2-4351-a3e8-2bb315a93633 61 fields · synced Oct 6, 2026
- FDA UDI 3cd393bc-c62b-44c9-ab31-7e7f8a9058c7 34 fields · synced May 30, 2026