SoWeCare LX-26E

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Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06973399670014 UDI-DI	Date16 Jun 2020Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: SoWeCare
Generic Name: Infrared patient thermometer, skin
Model / Reference: LX-26E

Primary DI / UDI-DI: 06973399670014
510(k) Number: K160816
FDA Product Code: FLL
GMDN Term: Infrared patient thermometer, skin

Device Class: Class II
Regulation Number: 880.2910
GUDID distribution status: In Commercial Distribution

Properties

Lot / Batch Number
Serial Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Expiration Date: No