HomeChinaHANGZHOU GSPMED MEDICAL APPLIANCES CO.,LTD.

HANGZHOU GSPMED MEDICAL APPLIANCES CO.,LTD.

China · 杭州 · www.lwellmedtech.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000018891Unified social credit code 913301836917065383

This company holds 1 NMPA certificates in China and has registrations in European Union, United States, Brazil, Taiwan, Australia, Israel — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
1China registrations
Class II 1
as of 2026-09-04
EUEuropean UnionEUDAMED
53UDI-DI device records
Class I 52Class IIb 1
USUnited StatesFDA openFDA
13listed device types
Class I 13Class II 0Class III 0
plus 13 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
5registered devices
Class I 5
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
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 Union53 raw hits, 0 excluded, 53 confirmed
United States13 registration records, 0 510(k), 0 PMA
China1 certificates (Class III 0 / II 1 / I 0), as of 2026-09-04
Brazil5 confirmed, 0 excluded
Manufacturer names merged into this page: Hangzhou GspMed Medical Appliances Co., Ltd. · HANGZHOU GSPMED MEDICAL APPLIANCES CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000018891
EU authorised representative
Prolinx GmbH
Unified social credit code
913301836917065383
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
99
Annual revenue
RMB 5–10M
Website
www.lwellmedtech.com
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
2009-07-06
Registered capital
CNY 23,000,000
Paid-in capital
CNY 23,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-01-26
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEInnovative SME

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 13
Bandage, Cast 1Scissors, Medical, Disposable 1Accessory, Surgical Apparel 1Pack, Hot Or Cold, Disposable 1Disinfectant, Medical Devices 1First Aid Kit Without Drug 1Dressing, Compression 1Bedding, Disposable, Medical 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20242141687冷敷弹力绷带Class II
EU06931346750356SpadermClass I
EU06931346750349SpadermClass I
EU06931346750318SPOPHY ULTRAGRIPClass I
EU06931346750332SPOPHYClass I
BR81284250044FITA KINESIO TAPE MERCURClass I
BR81284250046BANDAGEM AUTOADERENTE FRESH MERCURClass I
BR81284250047BANDAGEM AUTOADERENTE MERCURClass I

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