HomeChinaMiraclean Technology Co.,Ltd.

Miraclean Technology Co.,Ltd.

China · 深圳 · www.mrkl.cn
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000011683Unified social credit code 91440300687593702L

This company holds 41 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
41China registrations
Class I 27Class II 14
as of 2026-09-04
EUEuropean UnionEUDAMED
139UDI-DI device records
Class I 139
USUnited StatesFDA openFDA
4listed device types
Class I 4Class II 0Class III 0
plus 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 Union139 raw hits, 0 excluded, 139 confirmed
United States4 registration records, 0 510(k), 0 PMA
China41 certificates (Class III 0 / II 14 / I 27), as of 2026-09-04
Manufacturer names merged into this page: MIRACLEAN TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000011683
EU authorised representative
Share info GmbH
Unified social credit code
91440300687593702L
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
218
Annual revenue
RMB 100–500M
Website
www.mrkl.cn
Product categories
体外诊断

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
2009-05-04
Registered capital
CNY 12,000,000
Paid-in capital
CNY 11,280,000
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2023-02-13
Recognitions
National High-Tech EnterpriseSRDI SMEInnovative SME

Business registration data from Tianyancha, as of 2026-09-03. 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

Fluid, Bouin'S 1Applicator, Absorbent Tipped, Non-Sterile 1Applicator, Absorbent Tipped, Sterile 1Douche Apparatus, Vaginal, Therapeutic 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20242221354一次性使用无菌采样拭子Class II
CN粤械注准20242220269一次性使用无菌采样拭子Class II
CN粤械注准20242220268一次性使用无菌采样拭子Class II
CN粤械注准20242220152一次性使用无菌采样拭子Class II
EU06971893323245Class I
EU06971893323238Class I
EU06971893323221Class I
EU06971893323214Class I

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