EVERLY HEALTH, INC.

FDA Device Registration & Listing · Austin, TX, US · Registration 3036035508

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3036035508
FEI Number
3036035508
Entity Name
EVERLY HEALTH, INC.
City/State/Country
Austin, TX, US
Establishment Address
5209 Burnet Rd Unit 300, Austin, TX 78756, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Everly Health, Inc. (Owner Number: 10092657)
Owner / Operator Contact Address
5209 Burnet Road, Suite 300, Austin, TX 78756, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Everlywell Urine Collection Everlywell Blood Collection Everlywell

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2025-02-04
PQD Blood Specimen Collection Convenience Kit (Excludes Hiv) Clinical Chemistry Class 2 862.1675 2025-02-04
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2025-02-03

Official Correspondent

Alison Mancusi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Everly Health, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3004111573 Sterigenics US LLC Grand Prairie, TX, US
3021179642 NEELYX LABS Wood Dale, IL, US
8020040 GREINER BIO-ONE GMBH KREMSMUENSTER Oberosterreich, AT
3011057574 The Dot Printer Inc. Irvine, CA, US
3012683224 Realtime Laboratories, Inc Carrollton, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036035508. Last updated year: 2026. Please use registration number 3036035508 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.