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Rocgene Technology Co.,Ltd

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000024511Unified social credit code 91110302MA004N2T15

This company holds 1 NMPA certificates in China and has registrations in European Union, United States, United Kingdom — 3 overseas markets.

Registrations by market

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

CNChinaNMPA

1China registrations

Class I 1

as of 2026-09-04

EUEuropean UnionEUDAMED

54UDI-DI device records

IVD A 10IVD general 44

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

3registered device records

IVD general 3

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 Union54 raw hits, 0 excluded, 54 confirmed

United States1 registration records, 0 510(k), 0 PMA

China1 certificates (Class III 0 / II 0 / I 1), as of 2026-09-04

United Kingdom3 confirmed, 0 excluded

Manufacturer names merged into this page: ROCGENE(XUZHOU) TECHNOLOGY LIMITED

Regulatory identity

EU manufacturer SRN: CN-MF-000024511
EU authorised representative: Medunion S.L.
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91110302MA004N2T15
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2016-04-08
Registered capital: CNY 6,532,891
Paid-in capital: CNY 6,484,316
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-02-06
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseGazelle enterpriseRecognised enterprise technology centre

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.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	京昌械备20250011	全自动核酸提取纯化仪	Class I
EU	06974795550658	—	IVD general
EU	06974795550641	—	IVD general
EU	06974795550634	—	IVD general
EU	06974795550627	—	IVD general
UK	43472	Real-Time PCR System	IVD general
UK	48031	Full-Automatic Nucleic Acid Detection and Analyzer	IVD general
UK	48031	Real-Time PCR System	IVD general

Rocgene Technology Co.,Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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