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ri-cardio ABPM (24h BP device) w/cuffs for adults standard and large size
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ri-cardio ABPM (24h BP device) w/cuffs for adults standard and large size FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
- Device Name
- The ri-cardio is a non-invasive oscillometric long-term blood pressure monitor for measuring systolic and diastolic blood pressure in adult or pediatric patients. FDA UDI
- Model / Reference
- 1760 FDA UDI
- Description
- The ri-cardio is a non-invasive oscillometric long-term blood pressure monitor for measuring systolic and diastolic blood pressure in adult or pediatric patients. FDA UDI
Identifiers
- Catalog Number
- 1760 FDA UDI
- Primary DI / UDI-DI
- 04045396915091 FDA UDI
- 510(k) Number
- K003004 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, non-portable
ri-cardio ABPM (24h BP device) w/cuffs for adults standard and large size by Rudolf Riester GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Automatic-inflation electronic sphygmomanometer, non-portable.
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Cleared under the same submission
K003004 also covers:
- AccuWin — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rudolf Riester GmbH & Co. KG
Sources (1)
- FDA UDI 77f171be-1970-4dff-b126-350ab373f585 35 fields · synced May 30, 2026