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Safecare Biotech(Hangzhou)Co. Ltd.

✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000019109Unified social credit code 9133011005670527XT

This company holds 2 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Canada, Australia, Israel — 6 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

2China registrations

Class II 1Class III 1

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

IVD general 283ivd-devices-self-testing 17

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

USUnited StatesFDA openFDA

22listed device types

Class I 6Class II 15Class III 0unclassified 1

plus 14 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

36registered device records

IVD general 34IVD Devices for Self-Testing 2

BRBrazilANVISA

0registered devices

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

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 Union338 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States14 registration records, 9 510(k), 0 PMA, 1 excluded

China2 certificates (Class III 1 / II 1 / I 0), as of 2026-09-04

United Kingdom36 confirmed, 0 excluded

Manufacturer names merged into this page: SAFECARE BIOTECH(HANGZHOU)CO.,LTD · SAFECARE BIOTECH ( HANGZHOU) CO. LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000019109
EU authorised representative: NIC GmbH
UK responsible person: SHARE INFO LTD
Unified social credit code: 9133011005670527XT
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2012-11-07
Registered capital: CNY 6,100,000
Paid-in capital: CNY 5,977,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Professional technical services
Last approval date: 2022-04-02
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseSRDI 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 510(k) clearances by year

12016

22018

12019

22020

12021

12024

12025

FDA listed device types

showing 8 of 22

Test, Methamphetamine, Over The Counter 1Test, Barbiturate, Over The Counter 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Test, Opiates, Over The Counter 1Test, Amphetamine, Over The Counter 1Test, Tricyclic Antidepressants, Over The Counter 1Enzyme Immunoassay, Amphetamine 1Test, Propoxyphene, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20223400542	甲基安非他明（MET）检测试剂（胶体金法）	Class III
CN	浙械注准20242401178	人绒毛膜促性腺激素检测试剂（胶体金法）	Class II
EU	06974246460017	COVID-19 Antigen Rapid Test Kit (Swab)	ivd-devices-self-testing
EU	06974246460024	COVID-19 Antigen Rapid Test Kit (Swab)	ivd-devices-self-testing
EU	06974246463087	ingenecare® Ypač ankstyvas srovinis nėštumo testas	ivd-devices-self-testing
EU	06974246463100	ingencare® Něštumo testas kasetė	ivd-devices-self-testing
UK	51707	Strep A Rapid Test (Swab)	IVD general
UK	51747	Strep B Rapid Test	IVD general
UK	30519	Marijuana THC Rapid Test	IVD general
US	K242767	Safecare Urinary Tract Infection Test	2025-01-10
US	K240654	SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette	2024-04-10
US	K202453	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card	2021-03-24

Safecare Biotech(Hangzhou)Co. Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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