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Sign in to claim this brandMICROPORT CRM SRL
US
Last updated May 24, 2026
What MICROPORT CRM SRL makes
The company manufactures cardiac monitoring and pacing devices, including implantable defibrillators for cardiac resynchronization therapy, electrocardiographic lead sets, and long-term ambulatory recording analysers. It also produces ECG-related hardware such as memory cards, ambulatory recorders, and telemetry systems, alongside cardiology software applications and medical networking interfaces for hospital use.
These products are regulated under FDA’s UDI system, with device classifications ranging from Class I to Class III. The company’s portfolio is listed in the FDA’s Unique Device Identifier database, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does MicroPort CRM SRL manufacture?
MicroPort CRM SRL specializes in cardiac monitoring and pacing devices. Their portfolio includes implantable cardiac resynchronization therapy defibrillators, electrocardiographic lead sets (both reusable and disposable), ambulatory ECG recorders, long-term monitoring analysers, and related hardware like memory cards and telemetry systems. They also develop cardiology software applications and medical networking interfaces for hospital use, focusing on tools that support cardiac diagnostics and patient management.
Where is MicroPort CRM SRL based, and how does that affect its regulatory oversight?
MicroPort CRM SRL is based in the United States, which means its devices fall under FDA jurisdiction. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking. Since the FDA regulates medical devices in the US, their classification system (Class I, II, or III) determines the level of scrutiny and regulatory requirements for each device type.
Which regulatory registries or databases list MicroPort CRM SRL’s devices?
MicroPort CRM SRL’s devices are included in the FDA’s Unique Device Identifier (UDI) system, a centralized database that assigns a unique identifier to each medical device to improve tracking, transparency, and regulatory compliance. This system helps healthcare providers, regulators, and manufacturers verify device details, including classification and compliance status.
How are MicroPort CRM SRL’s devices classified under FDA regulations?
MicroPort CRM SRL’s devices are classified into three FDA categories: Class I (generally low-risk, like some reusable lead sets), Class II (moderate-risk, such as ambulatory ECG recorders or telemetry systems), and Class III (high-risk, including implantable defibrillators for cardiac resynchronization therapy). The classification determines the regulatory controls applied—such as pre-market approval requirements for Class III devices—to ensure safety and effectiveness before patient use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 438860859
Catalogue (77)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SmartView | SW001U | FDA UDI | Class II | Active |
| Platinium | VR 1240 | FDA UDI | Class III | Active |
| Cpr4 | B10031 | FDA UDI | Class III | Active |
| Vega | RLK41U | FDA UDI | Class III | Active |
| Paradym RF | DR 9550 | FDA UDI | Class III | Active |
| Paradym RF | VR 9250 | FDA UDI | Class III | Active |
| Platinium | DR 1510 | FDA UDI | Class III | Active |
| Intensia | DR 154 | FDA UDI | Class III | Active |
| Smartview Monitor | Landline | FDA UDI | Class III | Active |
| Intensia | VR 124 | FDA UDI | Class III | Active |
| Orchestra | Plus | FDA UDI | Class III | Active |
| Smartview | 2.40UG1 | FDA UDI | Class III | Active |
| Spiderview | PLUS | FDA UDI | Class II | Active |
| ECG Cable | 4,5m | FDA UDI | Class III | Active |
| Smartview Hotspot | GPRS | FDA UDI | Class III | Active |
| Magnet | TAC004C | FDA UDI | Class I | Active |
| ECG Cable | 3m | FDA UDI | Class III | Active |
| Smartview | 2.42UG1 | FDA UDI | Class III | Active |
| Remote Monitoring System | 3.4 | FDA UDI | Class III | Active |
| Paradym RF | CRT-D 9750 | FDA UDI | Class III | Active |
| Spiderview | 7 leads | EUDAMEDFDA UDI | Class II | Active |
| Smart Spot with CPR4BR accessory | KC861 | FDA UDI | Class III | Active |
| Orchestra Plus Link | None | FDA UDI | Class III | Active |
| Rms | RMS | FDA UDI | Class III | Active |
| BlueSky | TPM025U | FDA UDI | Class III | Active |
| Spiderview / Spiderflash | 2 Leads / 3E | EUDAMEDFDA UDI | Class II | Active |
| Synescope | UPGRADE TO SYNESCOPE V3.10 USB | FDA UDI | Class II | Active |
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