Identity
- Trade Name
- icompanion FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Model / Reference
- 2.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B621ICOMPANION2X1Y0 FDA UDI
- FDA Product Code
- NXQ FDA UDI
- GMDN Term
- Self-care monitoring/reporting software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Self-care monitoring/reporting software
icompanion by Icometrix NV — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Icometrix NV
Sources (2)
- FDA UDI 7f0e95dc-3bab-4dac-96a4-6f5a135e0778 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026