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AnHui Deepblue Medical Technology Co.;Ltd

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000018785Unified social credit code 913401005501903714

This company holds 34 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Hong Kong, Israel — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

34China registrations

Class I 12Class II 21Class III 1

as of 2026-09-04

EUEuropean UnionEUDAMED

263UDI-DI device records

IVD B 70IVD C 34IVD general 135ivd-devices-self-testing 24

USUnited StatesFDA openFDA

16listed device types

Class I 2Class II 13Class III 0unclassified 1

plus 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

8registered device records

IVD B 1IVD general 1Class B – Self-testing or Near-patient Testing 2Class C – Self-testing or Near-patient Testing 1IVD Devices for Self-Testing 3

BRBrazilANVISA

17registered devices

Class I 2Class II 15

34 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 1 1IVD Class 2 2

HKHong KongMDACS

3valid listings

IVD C 3

ILIsraelAMAR

14registrations

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 Union263 raw hits, 0 excluded, 263 confirmed

United States5 registration records, 3 510(k), 0 PMA

China34 certificates (Class III 1 / II 21 / I 12), as of 2026-09-04

United Kingdom8 confirmed, 0 excluded

Brazil17 confirmed, 0 excluded

Manufacturer names merged into this page: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. · ANHUI DEEPBLUE MEDICAL TECHNOLOGY., LTD · ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000018785
EU authorised representative: Mega Eurostar Sp. z o.o.
UK responsible person: KINGSMEAD SERVICE LIMITED
Unified social credit code: 913401005501903714
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2010-02-04
Registered capital: CNY 10,000,000
Paid-in capital: CNY 10,000,000
Legal form: Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification: Wholesale trade
Last approval date: 2023-06-26
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseSRDI SMERecognised enterprise technology centreInnovative 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

22024 · K240242

12025 · K250803

FDA listed device types

showing 8 of 16

Test, Barbiturate, Over The Counter 1Test, Methamphetamine, Over The Counter 1Visual, Pregnancy Hcg, Prescription Use 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Test, Opiates, Over The Counter 1Test, Benzodiazepine, Over The Counter 1Test, Amphetamine, Over The Counter 1Test, Cannabinoid, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20223401843	新型冠状病毒(2019-nCoV)抗原检测试剂盒(胶体金法)	Class III
CN	皖械注准20262400175	乳铁蛋白检测试剂盒（胶体金法）	Class II
CN	皖械注准20262400174	钙卫蛋白检测试剂盒（胶体金法）	Class II
CN	皖械注准20262400037	微量白蛋白（mALB）检测试剂盒（胶体金法）	Class II
EU	06952062713937	COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)	IVD B
EU	06952062713920	COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)	IVD B
EU	06952062713913	COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)	IVD B
EU	06952062713906	COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)	IVD B
UK	65665	Fecal Occult Blood (FOB)Test (Colloidal Gold)	IVD Devices for Self-Testing
UK	43740	HCG Pregnancy Test (Colloidal Gold)	Class B – Self-testing or Near-patient Testing
UK	65947	LH Ovulation Test (Colloidal Gold)	IVD B
US	K250803	Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup	2025-04-15
US	K240242	HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)	2024-10-11
US	K242167	Sterile and Non-Sterile Ultrasonic Coupling Agent	2024-09-19
BR	82444370300	Rotavirus Antigen Test Kit (Colloidal Gold)	Class II
BR	82444370301	One Step Multi-2 DOA Test (Colloidal Gold)	Class II
BR	82444370302	HCG Pregnancy Test 10 mIU (Urine/Serum/Plasma) (Colloidal Gold)	Class II

AnHui Deepblue Medical Technology 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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