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PeriWatch™ Curve™

FDA UDI

Class II (US FDA UDI)

by Perigen Solutions Ltd

Identity

Trade Name
PeriWatch™ Curve™ FDA UDI
Generic Name
Obstetrical monitoring/analysis software FDA UDI
Device Name
PeriWatch Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks. FDA UDI
Model / Reference
02.08.xx FDA UDI
Description
PeriWatch Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks. FDA UDI

Identifiers

Primary DI / UDI-DI
B087CURV02081 FDA UDI
510(k) Number
K052715 FDA UDI
FDA Product Code
HGM FDA UDI
GMDN Term
Obstetrical monitoring/analysis software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.2740 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Obstetrical monitoring/analysis software

PeriWatch™ Curve™ by Perigen Solutions Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Obstetrical monitoring/analysis software.

Cleared under the same submission

K052715 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Perigen Solutions Ltd

Sources (1)

  • FDA UDI afc953bf-0501-445a-a703-9c29524d821c 35 fields · synced May 30, 2026