Boston Scientific
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Boston Scientific EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Reusable ECG Cables EUDAMEDSingle Leadwire Replacement 1m FDA UDI
- Model / Reference
- Patient Leadwires - Boston Scientific EUDAMEDBS-70612NG-10 EUDAMEDFDA UDI
- Description
- Single Leadwire Replacement 1m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700506320455 EUDAMEDFDA UDI
- Basic UDI-DI
- 37005063ECGLeadBSCIS2 EUDAMED
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electrical-only medical device connection cable, reusable
Boston Scientific by Nissha Medical Technologies Sas — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37005063ECGLeadBSCIS2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nissha Medical Technologies Sas
- EUDAMED SRN
- FR-MF-000009791
Sources (2)
- EUDAMED b360bdf5-91a0-402d-a109-f208bc428345 61 fields · synced May 30, 2026
- FDA UDI a4b81530-11aa-4dcc-a57e-3bb8000d5a28 34 fields · synced May 30, 2026