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Meditech
FDA UDIClass II (US FDA UDI)
by MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT.
Identity
- Trade Name
- Meditech FDA UDI
- Generic Name
- Blood pressure ambulatory recorder FDA UDI
- Device Name
- The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring. FDA UDI
- Model / Reference
- ABPM-06 (BP6) FDA UDI
- Description
- The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05999056500068 FDA UDI
- 510(k) Number
- K201332 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
- 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Blood pressure ambulatory recorder
Meditech by MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
Sources (1)
- FDA UDI 3698080a-a2a4-4cc4-815d-c314929ada31 34 fields · synced May 30, 2026