Identity
- Trade Name
- SmartView FDA UDI
- Generic Name
- Cardiology information system application software FDA UDI
- Device Name
- SmartView Connect App FDA UDI
- Model / Reference
- SW001U FDA UDI
- Description
- SmartView Connect App FDA UDI
Identifiers
- Catalog Number
- SW001U FDA UDI
- Primary DI / UDI-DI
- 08031527019932 FDA UDI
- PMA Number
- P950029 FDA UDI
- FDA Product Code
- DRG FDA UDI
- GMDN Term
- Cardiology information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 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
No
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
No
FDA UDI
Category: Cardiology information system application software
SmartView by Microport Crm Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiology information system application software.
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- EZLink — SCOTTCARE CORPORATION, THE · Class II
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- Epicardia 5000 — MEDICOMP, INC. · Class II
Cleared under the same submission
P950029 also covers:
- BlueSky — MICROPORT CRM SRL
- BlueSky — MICROPORT CRM SRL
- BlueSky — MICROPORT CRM SRL
- BlueSky — MICROPORT CRM SRL
- Esprit — MICROPORT CRM SRL
- Esprit — MICROPORT CRM SRL
- Reply — MICROPORT CRM SRL
- Reply — MICROPORT CRM SRL
- Screwdriver — MICROPORT CRM SRL
- Smartview — MICROPORT CRM SRL
- Vega — MICROPORT CRM SRL
- Vega — MICROPORT CRM SRL
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
- Microport Crm Srl
Sources (1)
- FDA UDI 9ba81eda-25e4-4e79-b245-9271d727e3f5 35 fields · synced May 30, 2026