HomeChinaHangzhou Tappa Medical Technology Co., Ltd.

Hangzhou Tappa Medical Technology Co., Ltd.

China · 杭州 · www.tappamed.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000027753Unified social credit code 9133010867985663XW

This company holds 29 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel — 9 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
29China registrations
Class II 28Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class I 29Class IIa 270Class IIb 1
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
3listed device types
Class I 1Class II 2Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class I 1Class IIa 2Class IIb 1
BRBrazilANVISA
16registered devices
Class II 16
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
5valid device licences
Class II 5
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
IIa 3IIb 1
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
6registrations
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 Union350 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States3 registration records, 2 510(k), 0 PMA
China29 certificates (Class III 1 / II 28 / I 0), as of 2026-09-04
United Kingdom4 confirmed, 0 excluded
Brazil16 confirmed, 0 excluded
Manufacturer names merged into this page: Hangzhou Tappa Medical Technology Co., Ltd. · Hangzhou tappa medical Technology Co. Ltd. · HANGZHOU TAPPA MEDICAL TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000027753
EU authorised representative
Prolinx GmbH
UK responsible person
PROLINX GLOBAL LTD
Unified social credit code
9133010867985663XW
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
31
Annual revenue
RMB 100–500M
Website
www.tappamed.com
Product categories
手术室及急救

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
2008-09-05
Registered capital
CNY 5,000,000
Paid-in capital
CNY 5,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2023-10-19
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseGazelle enterpriseInnovative 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 510(k) clearances by year

22026 · K252861

FDA listed device types

Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) 1System, Thermal Regulating 1Airway, Oropharyngeal, Anesthesiology 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263140093一次性使用加温仪配套输血输液管路Class III
CN浙械注准20262080460一次性使用免充气喉罩气道导管Class II
CN浙械注准20262080142一次性使用呼吸过滤器套件Class II
CN浙械注准20262080015一次性使用PVC可视双腔支气管插管Class II
EUD-TMS-W101SGMedical Warming UnitClass IIb
EUD-DLB-XXSXTDisposable Laryngoscope BladeClass I
EUD-DLB-XSCTDisposable Laryngoscope BladeClass I
EUD-DLB-SWCDisposable Laryngoscope BladeClass I
UK58416Disposable Warming BlanketClass I
UK37329Medical Warming UnitClass IIb
UK31328Double Lumen Endobronchial TubeClass IIa
USK252861Warming System2026-04-07
USK251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)2026-03-20
BR81194869001Tubo endotraqueal sem cuff TappaClass II
BR81194860004Tubo Bloqueador endobronqueal auto inflador Endoblock TappaClass II
BR81194860006Tubo endotraqueal com cuff TappaClass II

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