Detachable PPG Clip sensor

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref PVC0365 Model PPG

by Viasonix Ltd

Identity

Trade Name: PPG Detachable Clip sensors EUDAMED
Detachable PPG Clip sensor FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: PPG Toe Clip sensors EUDAMED
The detachable PPG Clip sensor is similar in enclosure to a standard pulse oximeter. It is designed primarily to fit comfortably to the fingers. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures or other peripheral vascular diagnosis tests FDA UDI
Model / Reference: PPG EUDAMED
PVC0365 EUDAMED
Detachable PPG Clip sensor FDA UDI
Description: The detachable PPG Clip sensor is similar in enclosure to a standard pulse oximeter. It is designed primarily to fit comfortably to the fingers. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures or other peripheral vascular diagnosis tests FDA UDI

Identifiers

Primary DI / UDI-DI: 07290016880441 EUDAMEDFDA UDI
Basic UDI-DI: 729001688036CN EUDAMED
510(k) Number: K242662 FDA UDI
FDA Product Code: JOP FDA UDI
EMDN Code: Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 870.2880 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose ultrasound imaging system

Detachable PPG Clip sensor by Viasonix Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as General-purpose ultrasound imaging system.

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WS80A Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
HS50 / HS60 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
MEDISONO — Medisono, LLC · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Viasonix Ltd

Sources (2)

FDA UDI 073cc80e-14f8-4136-9922-15d651d640c0 34 fields · synced Sep 17, 2026
EUDAMED fece7054-febf-4c3f-90a8-3573d6572359 61 fields · synced Sep 17, 2026