Opal V2C

FDA UDI

Class II (US FDA UDI)

by Apdm, Inc.

Identity

Trade Name: Opal V2C FDA UDI
Generic Name: Kinesiology ambulatory recorder FDA UDI
Device Name: APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable. FDA UDI
Model / Reference: V2C FDA UDI
Description: APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable. FDA UDI

Identifiers

Catalog Number: OPALV2C FDA UDI
Primary DI / UDI-DI: B628OPALV2C0 FDA UDI
FDA Product Code: ISD FDA UDI
GMDN Term: Kinesiology ambulatory recorder FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Kinesiology ambulatory recorder

Opal V2C by Apdm, Inc. — 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

Manufacturer: Apdm, Inc.

Sources (1)

FDA UDI e26423fe-a8bf-4ff8-9b2b-c849eed13404 36 fields · synced Jun 6, 2026