Fainteer Limited

FDA Device Registration & Listing · Littleton, CO, US · Registration 3031506335

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
3031506335
FEI Number
3031506335
Entity Name
Fainteer Limited
City/State/Country
Littleton, CO, US
Establishment Address
5306 S Bannock St Ste 207, Littleton, CO 80120, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Fainteer Limited (Owner Number: 10090514)
Owner / Operator Contact Address
5306 S BANNOCK ST STE 207, Littleton, CO 80120, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K921273
PMA Number
N/A

All Registered Proprietary Names

Nebulizer; Portable Nebulizer; Ultrasonic Mesh Nebulizer for Breathing Problems; Model: 503, Part: #17068 Auglam Nebulizer, Portable Nebulizer, Ultrasonic Nebulizer(Model: NO. M-175) Portable Nebulizer, Ultrasonic Nebulizer (OTC use) Nebulizer, Portable Nebulizer, Ultrasonic Nebulizer, Nebulizer Machine for Adults &Kids Nebulizer, Portable Nebulizer, Ultrasonic Nebulizer, Nebulizer Machine for Adults &Kids Use 77 Ultrasonic Nebulizer Easimist Ultrasonic Nebulizer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2024-07-20
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2024-04-08
NVO Spacer, Direct Patient Interface Anesthesiology Class 2 868.5630 2026-06-05
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2024-04-08
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2024-04-07
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2024-07-20
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2025-04-27

Official Correspondent

Xingwang Zhang Zhang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fainteer Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30
K781467 Travenol Laboratories, S.A. U-FLOAT VALVE 2D9023 1978-09-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031506335. Last updated year: 2026. Please use registration number 3031506335 when referencing this establishment in official correspondence.
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