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Finapres

FDA UDI

Class II (US FDA UDI)

by Finapres Medical Systems B.V.

Identity

Trade Name
Finapres FDA UDI
Generic Name
Patient monitoring system module, blood pressure, noninvasive FDA UDI
Device Name
Finapres NOVA Main Unit FDA UDI
Model / Reference
Finapres NOVA Main Unit FDA UDI
Description
Finapres NOVA Main Unit FDA UDI

Identifiers

Catalog Number
FP_910901 FDA UDI
Primary DI / UDI-DI
08719327003664 FDA UDI
510(k) Number
K141460 FDA UDI
K160967 FDA UDI
FDA Product Code
DXN FDA UDI
DSB FDA UDI
GMDN Term
Patient monitoring system module, blood pressure, noninvasive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
870.2770 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

No

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

Category: Patient monitoring system module, blood pressure, noninvasive

Finapres by Finapres Medical Systems B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, blood pressure, noninvasive.

Cleared under the same submission

K141460 also covers:

K160967 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Finapres Medical Systems B.V.

Sources (1)

  • FDA UDI 732587b3-5909-4053-a894-78bf4aab490f 35 fields · synced Jun 8, 2026