HomeChinaWenzhou KLF Medical Plastics Co., Ltd.

Wenzhou KLF Medical Plastics Co., Ltd.

China · Wenzhou Zhejiang · www.klfmed.com
✓ Record-verifiedregistrations found in 4 marketsUnified social credit code 91330303145262183T

This company holds 7 NMPA certificates in China and has registrations in United States, Brazil, Israel — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
7China registrations
Class I 1Class II 2Class III 4
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
4listed device types
Class I 2Class II 2Class III 0
plus 5 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
16registered devices
Class I 7Class II 9
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
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.

United States5 registration records, 7 510(k), 0 PMA, 162 excluded
China7 certificates (Class III 4 / II 2 / I 1), as of 2026-09-04
Brazil16 confirmed, 0 excluded
Manufacturer names merged into this page: WENZHOU K.L.F. MEDICAL PLASTICS CO., LTD. · WENZHOU KLF MEDICAL PLASTIC CO., LTD. · WENZHOU KLF MEDICAL PLASTIC CO., LTD

Regulatory identity

Unified social credit code
91330303145262183T
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Wenzhou Zhejiang
Social-insurance enrolees
207
Annual revenue
RMB 100–500M
Website
www.klfmed.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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
1991-02-28
Registered capital
CNY 15,000,000
Paid-in capital
CNY 15,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2023-04-03
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseAbove-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 510(k) clearances by year

11978 · K781148
21982 · K822072
31989 · K896088
11990 · K902384

FDA listed device types

Set, Administration, Intravascular 1Catheter And Tip, Suction 1Applicator, Absorbent Tipped, Non-Sterile 1Evacuator, Oral Cavity 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243141521一次性使用滴定管式输液器Class III
CN国械注准20243141184一次性使用微孔过滤输液器Class III
CN国械注准20183140195一次性使用输液用肝素帽Class III
CN国械注准20173141611一次性使用三通阀Class III
USK902384ABDOMINAL OR C-SECTION DRAPE SHEET1990-08-09
USK896088FEMORAL ANGIOGRAPHY DRAPE1989-11-17
USK895404UNDER BUTTOCKS DRAPE1989-10-06
BR80884749007GI ApplicatorsClass II
BR80288099039Conector ValvuladoClass II
BR80288099040Torneira Três ViasClass II

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