Identity
- Trade Name
- RHYTHMIA HDx™ FDA UDI
- Generic Name
- Transducer signal amplifier FDA UDI
- Device Name
- Signal Station FDA UDI
- Model / Reference
- M004RH1020H0 FDA UDI
- Description
- Signal Station FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729965862 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Transducer signal amplifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Transducer signal amplifier
RHYTHMIA HDx™ by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Transducer signal amplifier.
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- RHYTHMIA HDx™ — Boston Scientific · Class II
- Rhythmia™ Mapping System — Boston Scientific · Class II
- RHYTHMIA HDx™ — Boston Scientific · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 174ee33e-1a1e-4c2e-bdf6-b7d0ba2ea531 33 fields · synced Jun 8, 2026