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Ambulatory Blood Pressure Monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SA-10Ref SA-09Ref SA-08
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-10 EUDAMEDFDA UDISA-09 EUDAMEDFDA UDISA-08 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413812574 EUDAMEDFDA UDI06944413812581 EUDAMEDFDA UDI06944413812598 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Ambulatory Blood Pressure Monitor by Edan Instruments, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69444138SAS4S | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED 1b4b5b14-2ca7-4b2d-9237-c5dc7bf77357 61 fields · synced Oct 6, 2026
- FDA UDI ca2d0f42-61ba-4fec-a3a8-fad59ac6882b 33 fields · synced May 30, 2026
- FDA UDI 856f6cf5-457e-4c28-b2a0-a602bf65ea2e 33 fields · synced May 30, 2026
- FDA UDI 2369f90c-81d2-479f-ae44-19b33d62bcb6 33 fields · synced May 30, 2026
- EUDAMED 3db57371-985f-42c1-a9d2-704e36213c6d 61 fields · synced Jul 18, 2026
- EUDAMED 562618a9-e52f-42fc-ad6d-330d99ea097c 61 fields · synced Aug 3, 2026