Identity
- Trade Name
- ScottCare FDA UDI
- Generic Name
- Blood pressure ambulatory recorder FDA UDI
- Model / Reference
- ABP 320 FDA UDI
Identifiers
- Catalog Number
- M25108200 FDA UDI
- Primary DI / UDI-DI
- 04041346100098 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Blood pressure ambulatory recorder 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
Yes
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
MR Unsafe FDA UDI
ScottCare 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 31a456c7-cd4d-429d-9ba2-f2dc72ca3b27 36 fields · synced May 31, 2026