Identity
- Trade Name
- ABPM pro basic device FDA UDI
- Generic Name
- Blood pressure ambulatory recorder FDA UDI
- Model / Reference
- ABP050U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250413405640 FDA UDI
- 510(k) Number
- K231104 FDA UDI
- FDA Product Code
- DSH FDA UDIDXN FDA UDI
- GMDN Term
- Blood pressure ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 FDA UDI870.1130 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood pressure ambulatory recorder
ABPM pro basic device by Somnomedics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Somnomedics GmbH
Sources (1)
- FDA UDI f7ff6784-4e20-4c84-a479-6862e0144b3c 33 fields · synced Jun 8, 2026