HomeChinaANJI HONGDE MEDICAL PRODUCTS CO.,LTD.

ANJI HONGDE MEDICAL PRODUCTS CO.,LTD.

China · 湖州
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000008472Unified social credit code 91330523785653430W

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class I 3Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
35UDI-DI device records
Class I 35
USUnited StatesFDA openFDA
47listed device types
Class I 42Class II 2Class III 0unclassified 3
plus 48 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class I 2
BRBrazilANVISA
9registered devices
Class I 9
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
26registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
5valid device licences
Class I 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
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 Union36 raw hits, 1 excluded, 35 confirmed
United States48 registration records, 0 510(k), 0 PMA
China5 certificates (Class III 0 / II 2 / I 3), as of 2026-09-04
United Kingdom2 confirmed, 1 excluded
Brazil9 confirmed, 0 excluded
Saudi Arabia26 confirmed, 0 excluded
Manufacturer names merged into this page: ANJI HONGDE MEDICAL PRODUCTS CO., LTD. · ANJI HONGDE MEDICAL PRODUCTS CO., LTD · Anji Hongde Medical Products CO. LTDA

Regulatory identity

EU manufacturer SRN
CN-MF-000008472
EU authorised representative
SUNGO Europe B.V.
UK responsible person
PRAXIS MEDICAL LTD
Unified social credit code
91330523785653430W
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
224
Annual revenue
RMB 50–100M
Product categories
医用耗材

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2006-02-13
Registered capital
CNY 1,600,000
Paid-in capital
CNY 1,600,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-03-26
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEAbove-designated-size industrial enterprise

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 listed device types

showing 8 of 47
Marker, Skin 1Cap, Surgical 1Pad, Eye 1Device, Occlusion, Umbilical 1Mask, Oxygen, Non-Rebreathing 1First Aid Kit Without Drug 1Slides, Microscope 1Mask, Gas, Anesthetic 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20262140258纱布片Class II
CN浙械注准20252071969压舌板Class II
CN浙湖械备20260049医用压敏胶带Class I
CN浙湖械备20260013自粘弹性绷带Class I
EU06970226431268Self-Adhesive Bandages/ Cohesive BandagesClass I
EU06970226431251Self-Adhesive Bandages/ Cohesive BandagesClass I
EU06970226431244Self-Adhesive Bandages/ Cohesive BandagesClass I
EU06970226431992Self-Adhesive Bandages/ Cohesive BandagesClass I
UK10669Casting Stockinette TapeClass I
UK66337Cotton Crepe Bandage TapeClass I
BR83370710001Fita cirurgica/ esparadrapo/ fita atlética de poliester e algodãoClass I
BR82906670003MicrotecClass I
BR82906670004Curativo Redondo pós coletaClass I
SAME0000010888SFDAA00110PLASTER OF PARIS BANDAGE
SAME0000010888SFDAA00080HD PLASTER OF PARIS BANDAGE

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