Home›China›Promisemed Hangzhou Meditech Co.,Ltd.

Promisemed Hangzhou Meditech Co.,Ltd.

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000008465Unified social credit code 91330110060952927C

This company holds 31 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 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

31China registrations

Class I 1Class II 19Class III 11

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 7Class IIa 291Class IIb 2

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

USUnited StatesFDA openFDA

21listed device types

Class I 6Class II 15Class III 0

plus 50 registration records and 35 510(k)

UKUnited KingdomMHRA PARD

20registered device records

Class I 5Class IIa 13Class IIb 1System or Procedure Pack 1

BRBrazilANVISA

56registered devices

Class I 4Class II 52

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

10 including historic records

TWTaiwanTFDA

11valid device licences

Class I 5Class II 6

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

6active ARTG entries

IIa 5IIb 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 7

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 Union1,197 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States50 registration records, 35 510(k), 0 PMA

China31 certificates (Class III 11 / II 19 / I 1), as of 2026-09-04

United Kingdom20 confirmed, 0 excluded

Brazil56 confirmed, 0 excluded

Manufacturer names merged into this page: PROMISEMED HANGZHOU MEDITECH CO.,LTD. · PROMISEMED HANGZHOU MEDITECH CO., LTD. · PROMISEMED HANGZHOU MEDITECH CO, LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000008465
EU authorised representative: Obelis s.a.
UK responsible person: LC & Partners UK Ltd
Unified social credit code: 91330110060952927C
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2013-01-28
Registered capital: CNY 52,914,000
Paid-in capital: CNY 52,914,000
Legal form: Joint-stock limited company (listed)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2026-06-17
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEAbove-designated-size industrial enterprise
Listing: Listed on the A-share marketDelisted from the NEEQ

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

12017

32019

22020

82021

52022

52023

32024

52025

32026

FDA listed device types

showing 8 of 21

Forceps, Biopsy, Non-Electric 1Syringe, Irrigating (Non Dental) 1System, Blood Collection, Vacuum-Assisted, Manual 1Needle, Aspiration And Injection, Disposable 1Gauze / Sponge,Nonresorbable For External Use 1Insulin Vial Protector/Holder 1Container, Sharps 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20253142037	一次性使用钝末端注射针	Class III
CN	国械注准20253140631	一次性使用内窥镜注射针	Class III
CN	国械注准20253010436	一次性使用热活检钳	Class III
CN	国械注准20243140157	植入式给药装置专用针及附件	Class III
EU	06980118031049	Soludiab	Class IIa
EU	06980118031032	Versafe	Class IIa
EU	06980118031025	Versafe	Class IIa
EU	06980118031018	Versafe	Class IIa
UK	13913	Alcohol Swabs	Class I
UK	44127	4 SURE Insulin Pen Needles	Class IIa
UK	58497	VeriSafe® Safety winged blood collection sets	Class IIa
US	K261196	Promisemed VeriEcto Automatic Biopsy Needles	2026-05-12
US	K261045	Verifine Safety Lancets	2026-05-01
US	K254273	Verisafe Safety Sterile Needles (SSN)	2026-04-16
BR	80937159047	NEEDS AGULHA PARA CANETA DE INSULINA	Class II
BR	80937159058	SOL-CARE AGULHA PARA COLETA MÚLTIPLA DE SANGUE A VÁCUO PMM	Class II
BR	80937159059	SOL-M AGULHA PARA COLETA MÚLTIPLA DE SANGUE A VÁCUO PMM	Class II