Ambulatory Blood Pressure Monitor
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Ambulatory Blood Pressure Monitor EUDAMEDFDA UDI
- Generic Name
- Blood pressure ambulatory recorder FDA UDI
- Device Name
- Ambulatory Blood Pressure Monitor EUDAMED
- Model / Reference
- SA-06 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413812604 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138SAS4S EUDAMED
- 510(k) Number
- K210139 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z12050404 BLOOD PRESSURE HOLTER RECORDERS EUDAMED
- GMDN Term
- Blood pressure ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Blood pressure ambulatory recorder
Ambulatory Blood Pressure Monitor by Edan Instruments, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood pressure ambulatory recorder.
- Microlife — MICROLIFE USA, INC. · Class II
- AccuWin — SUNTECH MEDICAL, INC. · Class II
- SunTech — SUNTECH MEDICAL, INC. · Class II
- BPL — SUNTECH MEDICAL, INC. · Class II
- Welch Allyn — I.E.M. GmbH · Class II
- Oscar 2 — SUNTECH MEDICAL, INC. · Class II
- SunTech — SUNTECH MEDICAL, INC. · Class II
- Mobil-O-Graph — I.E.M. GmbH · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Edan Instruments, Inc.
Sources (2)
- FDA UDI 0c5c22ba-39bf-4686-95cb-c8a40242069e 33 fields · synced Oct 6, 2026
- EUDAMED ab4341b0-0a77-4234-bebc-7cc24c46e0ee 61 fields · synced Oct 5, 2026