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Electrophysiology Cable, Controller to Pump or Remote
EUDAMEDFDA UDIClass I (EU MDR)
Ref M0046640
Identity
- Trade Name
- Electrophysiology Cable FDA UDI
- Generic Name
- Cardiac ablation system cable, reusable FDA UDI
- Device Name
- Electrophysiology Cable, Controller to Pump or Remote EUDAMEDCONTROLLER TO PUMP OR REMOTE CONTROL FDA UDI
- Model / Reference
- M0046640 EUDAMEDFDA UDI
- Description
- CONTROLLER TO PUMP OR REMOTE CONTROL FDA UDI
Identifiers
- Catalog Number
- M0046640 FDA UDI
- Primary DI / UDI-DI
- 08714729861904 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000154MU EUDAMED
- FDA Product Code
- OAD FDA UDI
- EMDN Code
- C0280 ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Cardiac ablation system cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Electrophysiology Cable, Controller to Pump or Remote by Boston Scientific Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 01915060000000000000154MU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 66be0d17-7b70-4e61-a243-b24b94aa30e7 61 fields · synced Jul 31, 2026
- FDA UDI 028a7bf3-f342-4266-8e45-cb1a3adae883 35 fields · synced May 30, 2026