Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010395155

FEI Number

3010395155

Entity Name

LOTFANCY INC

City/State/Country

Ontario, CA, US

Establishment Address

720 S Rochester Unit B, Ontario, CA 91761, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

LOTFANCY INC (Owner Number: 10044818)

Owner / Operator Contact Address

720 S Rochester Unit B, Ontario, CA 91761, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDLOT LOTFANCY LOTFANCY MEDLOT MEDLOT LOTFANCY LOTFANCY MEDLOT LOTFANCY MEDLOT MEDLOT LOTFANCY MEDLOT LOTFANCY LOTFANCY MEDLOT LOTFANCY MEDLOT LOTFANCY MEDLOT MEDLOT LOTFANCY MEDLOT LOTFANCY LOTFANCY MEDLOT Lotfancy Medlot MEDLOT LOTFANCY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2020-04-10
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-04-10
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-04-10
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2020-04-10
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-04-10
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2020-04-10
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-04-10
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-03-10
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2020-04-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-04-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-04-10
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-04-10
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2020-04-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-04-10
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2020-04-10

Official Correspondent

Heping Ding

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LOTFANCY INC

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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010395155. Last updated year: 2026. Please use registration number 3010395155 when referencing this establishment in official correspondence.