Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015456954

FEI Number

3015456954

Entity Name

ZHEJIANG LONGMED MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Huzhou Zhejiang, CN

Establishment Address

Building 8, No.277 Shuangshan Road, Fuxi Street, Deqing, Huzhou Zhejiang 313200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang Longmed Medical Technology Co., Ltd. (Owner Number: 10060278)

Owner / Operator Contact Address

Building 8, No.277 Shuangshan Road, Fuxi Street, Deqing, Huzhou, CN-ZJ 313200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Snore Stopper, Nasal Strips for Snoring, Nasal Strips, Anti Snoring Devices First Aid Kit, Emergency Medical Kit Posture Corrector, Posture Brace Toe Corrector Drop Foot Brace Arch Support Sleeves Preformed Tooth Positioner Anti-snoring Braces Teeth Braces Lip Trainer Mouth Guard, Lubyd Infrared Heating Waist Belt Red Infrared Light Therapy Lamp Heat Therapy Knee Pads Vibration Massage Knee Brace Red Light Mask Red Light Glasses Red Light Knee Brace Deep Breathing Trainer; Breath Training Device; Breathing Trainer; Breather Fit Loop Switch Earplugs Ear Plugs Ear Plugs for Sleeping Noise Cancelling Mask Isolation Mask Eye Shield Face Shield Wound Closure Device Sinus Rinse Machine Nasal Irrigation System Gauze Pad, Sponge Swab, Bandage Bed Rails Bed Slide Assist Handle Foam Dressing Hydrocolloid Foam Dressing NPWT Dressing Super Absorbency Dressing Silicone Dressing Hydrocolloid Dressing Nonwoven wound dressing Transparent Dressing Eye Shield Protective Eyewear Goggle Safety Glasses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2024-09-24
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2025-06-30
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2025-07-08
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2023-02-21
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2022-08-30
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-04-30
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2024-08-01
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2024-12-11
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-21
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-02
FZQ	Clip, Removable (Skin)	General, Plastic Surgery	Class 1	878.4320	2019-04-19
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2024-05-20
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2025-06-30
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2023-08-05
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-03-24
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-05-09

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: Ircfda@Gmail.Com Phone: (931) 6254938

Related Public Records

Same Entity

Zhejiang Longmed Medical Technology Co., Ltd.

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

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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3016450032	PLANET HOLDINGS LIMITED	Hong Kong, HK
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015456954. Last updated year: 2026. Please use registration number 3015456954 when referencing this establishment in official correspondence.