Home›China›Zhende Medical Co., Ltd.

Zhende Medical Co., Ltd.

China · Shaoxing Zhejiang · www.zhende.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000009961Unified social credit code 91330600609661634M

This company holds 139 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, South Korea, Australia, Israel — 9 overseas markets. EU UDI-DI records ≥30, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

139China registrations

Class I 37Class II 93Class III 9

as of 2026-09-04

EUEuropean UnionEUDAMED

≥30UDI-DI device records

Class I 26Class IIb 4

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

15listed device types

Class I 12Class II 3Class III 0

plus 21 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

71registered device records

Class I 62Class IIa 5Class IIb 4

BRBrazilANVISA

25registered devices

Class I 23Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

10registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

6valid device licences

Class I 6

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

11active ARTG entries

Class I 6IIb 2Class Is (sterile) 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

20registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union1,058 raw hits, 270 excluded, 30 confirmed. Large result set — only the first 300 verified

United States21 registration records, 2 510(k), 0 PMA, 1 excluded

China139 certificates (Class III 9 / II 93 / I 37), as of 2026-09-04

United Kingdom71 confirmed, 1 excluded

Brazil25 confirmed, 0 excluded

Saudi Arabia10 confirmed, 0 excluded

Manufacturer names merged into this page: ZHENDE MEDICAL CO., LTD. · HENAN ZHENDE MEDICAL PRODUCTS CO., LTD · SHAOXING ZHENDE MEDICAL CO., LTD · Zhende Medical Co., Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000009961
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Rocialle Healthcare Limited
Unified social credit code: 91330600609661634M
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 1994-08-18
Registered capital: CNY 263,876,225
Paid-in capital: CNY 263,876,225
Legal form: Joint-stock limited company (listed, natural-person invested or controlled)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2026-04-28
Recognitions: National High-Tech EnterpriseState Key LaboratoryAbove-designated-size industrial enterprise
Listing: Listed on the A-share market

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12020 · K201729

12021 · K210020

FDA listed device types

showing 8 of 15

Mask, Surgical 1Gown, Surgical 1Drape, Surgical, Exempt 1Ostomy Care Kit 1Dressing, Wound, Hydrophilic 1Gauze / Sponge,Nonresorbable For External Use 1Non-Surgical Gown 1Protector, Ostomy 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20253142274	可吸收胶原蛋白止血海绵	Class III
CN	国械注准20233141406	硅凝胶泡沫敷料	Class III
CN	国械注准20213141025	聚氨酯泡沫敷料	Class III
CN	国械注准20213140113	细菌纤维素敷料	Class III
EU	06942613731077	Compresse de Paraffine	Class IIb
EU	06942613731046	Pansement chirurgical adhésif	Class I
EU	06942613731015	Pansement chirurgical adhésif	Class I
EU	06942613730988	Pansement chirurgical adhésif	Class I
UK	47011	Sterile Wound Bandage	Class I
UK	58964	Non-sterile Cohesive Bandage	Class I
UK	48131	Sterile Non-woven Products	Class I
US	K210020	Medical Mask	2021-04-28
US	K201729	Medical Mask	2020-12-03
BR	80808480070	Anel Moldável para Estomia BeCare	Class I
BR	80808480074	Pó para Estomia BeCare	Class I
BR	80808480071	Fita Adesiva para Estomia BeCare	Class I
SA	ME0000011116SFDAA00058	BANDAGE, COHESIVE, ELASTIC CONFORMING BANDAGE 12 CM X 4 M	—
SA	ME0000011116SFDAA00061	PLASTER OF PARIS Size: 7.5 X 270CM	—

Zhende Medical Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies