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medisana

FDA UDI

Class II (US FDA UDI)

by Medisana GmbH

Identity

Trade Name
medisana FDA UDI
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Device Name
Blood Pressure Meter FDA UDI
Model / Reference
BU 510 FDA UDI
Description
Blood Pressure Meter FDA UDI

Identifiers

Catalog Number
99976 FDA UDI
Primary DI / UDI-DI
04015588999765 FDA UDI
510(k) Number
K160019 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
Commercial Distribution
Not 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

Yes

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
MRI Safety
MR Safe FDA UDI

medisana by Medisana GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K160019 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medisana GmbH

Sources (1)

  • FDA UDI 62c2265f-174c-4d78-b856-0d6ec88438cf 36 fields · synced May 31, 2026