Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004857344

FEI Number

3004857344

Entity Name

Zhejiang Changdi Medical Co., Ltd.

City/State/Country

JINHUA Zhejiang, CN

Establishment Address

3RD FLOOR NO.468 HANNING EAST ROAD, WUNING STREE, DONGYANG CITY, JINHUA Zhejiang 322100, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zhejiang Changdi Medical Co., Ltd. (Owner Number: 9067695)

Owner / Operator Contact Address

3RD FLOOR NO.468 HANNING EAST ROAD, WUNING STREE, DONGYANG CITY, JINHUA, CN-ZJ 322100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SOAP TOWELETTE CLEANSING SWAB ALCOHOL PREP PAD WIPES ANTISEPTIC POVIDONE-IODINE BZK STICK STING RELIEF Cold Pack Ice Pack,Hot Pack Instant cold compress/pack First aid kit,Heat pack SODIUM CHLORIDE SOLUTION First Aid Kit with drug DISINFECTED ADHESIVE BANDAGE DISINFECTED FLEXIBLE FABRIC BANDAGE BANGTIAN BRAND Antibacterial Adhesive Bandage First aid kit, Reusable Cold Pack Cold & Hot Pack KN95 Mask Disinfected Elastic Bandage First aid kit, SAFETY PIN First aid kit, Forceps/Tweezers First aid kit, Face shield Disposable Mask Non-surgical Mask First aid kit, Sterile eye pad First aid kit, Scissors First aid kit, Wound dressing Sterile Medical Dressing Transparent wound dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2010-01-14
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2010-03-31
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2010-03-31
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2007-12-01
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2006-05-12
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2010-03-31
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-17
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2004-10-27
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-03-31
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2010-03-31
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2010-03-31
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2010-03-31
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-03-31
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2010-03-31

Official Correspondent

No official correspondent registered.

US Agent Details

CHARLES MACK Business: IRC USA Email: ircfda@gmail.com Phone: (931) 9378093

Related Public Records

Same Entity

Zhejiang Changdi Medical 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
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.

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3008697511	Geann Industrial Co Ltd	Lukang Town Changhua, TW
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004857344. Last updated year: 2026. Please use registration number 3004857344 when referencing this establishment in official correspondence.