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Vasomedical-Biox™ 1805 Ambulatory Blood Pressure Monitor With Analysis S/W
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 04.18.050001Model Model 1805
Identity
- Trade Name
- Vasomedical-Biox™ 1805 Ambulatory Blood Pressure Monitor With Analysis S/W FDA UDI
- Generic Name
- Blood pressure ambulatory recorder FDA UDI
- Device Name
- Vasomedical-Biox™ 1805 Ambulatory Blood Pressure Monitor With Analysis S/W EUDAMEDAmbulatory Blood Pressure Recorder FDA UDI
- Model / Reference
- Model 1805 EUDAMEDFDA UDI04.18.050001 EUDAMED
- Description
- Ambulatory Blood Pressure Recorder FDA UDI
Identifiers
- Catalog Number
- A10-0088 FDA UDI
- Primary DI / UDI-DI
- 00817980020047 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817980021805Z9 EUDAMED
- 510(k) Number
- K111096 FDA UDI
- FDA Product Code
- DSH 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
- 870.2800 FDA UDI
- Market of Registration
- Italy 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Vasomedical-Biox™ 1805 Ambulatory Blood Pressure Monitor With Analysis S/W by Vasomedical, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0817980021805Z9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Vasomedical Inc.
- EUDAMED SRN
- US-MF-000030121
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (2)
- EUDAMED fe1d4c7a-285a-4a56-8954-1f5329568b68 61 fields · synced Jun 19, 2026
- FDA UDI 6c1e22dc-5a99-4c53-9417-ee2a06fe8934 37 fields · synced May 30, 2026