ZHENDE MEDICAL CO., LTD.

FDA Device Registration & Listing · SHAOXING Zhejiang, CN · Registration 3003348807

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
3003348807
FEI Number
3003348807
Entity Name
ZHENDE MEDICAL CO., LTD.
City/State/Country
SHAOXING Zhejiang, CN
Establishment Address
GAOBU TOWN, SHAOXING Zhejiang 312035, CN
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Zhende Medical Co., Ltd (Owner Number: 9050974)
Owner / Operator Contact Address
GAOBU TOWN, --, SHAOXING, ZHEJIANG PROVINCE, CN-ZJ 312035, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Isosafe™ Earloop Procedure Mask(Blue,Yellow) Ostomy ring

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2020-12-07
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2020-04-09
EXE Protector, Ostomy Gastroenterology, Urology Class 1 876.5900 2021-08-10
MDA Elastomer, Silicone, For Scar Management General, Plastic Surgery Class 1 878.4025 2024-04-02
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2009-11-05
FQM Bandage, Elastic General Hospital Class 1 880.5075 2002-04-29
EZR Cement, Stomal Appliance, Ostomy Gastroenterology, Urology Class 1 876.5900 2020-12-08
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2003-07-10
PQE Ostomy Care Kit Gastroenterology, Urology Class 1 876.5900 2020-05-28
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2002-08-06
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2021-04-02
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2018-06-05

Official Correspondent

Ming Chen

US Agent Details

Leeyeo Kee Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Zhende 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
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09
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

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 3003348807. Last updated year: 2026. Please use registration number 3003348807 when referencing this establishment in official correspondence.
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