Identity
- Trade Name
- IEM GmbH FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- Hypertension Management Software Version 6 FDA UDI
- Model / Reference
- HMS CS 6.2.x FDA UDI
- Description
- Hypertension Management Software Version 6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04041346102153 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
IEM GmbH by I.E.M. GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- I.E.M. GmbH
Sources (1)
- FDA UDI 9ebf9588-2242-4e03-94e9-3c3afc150d0c 34 fields · synced May 29, 2026