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Strados Labs

FDA UDI

Class II (US FDA UDI)

by Strados Labs

Identity

Trade Name
Strados Labs FDA UDI
Generic Name
Cough ambulatory recording system FDA UDI
Device Name
Wearable Device, SWD1, Boxed & Labeled FDA UDI
Model / Reference
SWD1 FDA UDI
Description
Wearable Device, SWD1, Boxed & Labeled FDA UDI

Identifiers

Catalog Number
810-00007 FDA UDI
Primary DI / UDI-DI
00850043625018 FDA UDI
FDA Product Code
DSH FDA UDI
GMDN Term
Cough ambulatory recording system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2800 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cough ambulatory recording system

Strados Labs by Strados Labs — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cough ambulatory recording system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Strados Labs

Sources (1)

  • FDA UDI 36c9d074-7cdc-4a90-9040-b7a23b43ea3c 34 fields · synced May 30, 2026