HomeChinaGuilin Royalyze Medical Instrument Co., Ltd.

Guilin Royalyze Medical Instrument Co., Ltd.

China · 桂林 · www.royalyze.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000038422Unified social credit code 91450300796840020F

This company holds 19 NMPA certificates in China and has registrations in European Union, United Kingdom — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
19China registrations
Class II 19
as of 2026-09-04
EUEuropean UnionEUDAMED
6UDI-DI device records
ivd-annex-ii-list-b 2ivd-devices-self-testing 4
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
6registered device records
IVD Annex II List B 2IVD Devices for Self-Testing 4
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 Union6 raw hits, 0 excluded, 6 confirmed
China19 certificates (Class III 0 / II 19 / I 0), as of 2026-09-04
United Kingdom6 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN
CN-MF-000038422
EU authorised representative
Caretechion GmbH
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91450300796840020F
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
65
Annual revenue
RMB 50–100M
Website
www.royalyze.com
Product categories
健康管理

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
2007-02-02
Registered capital
CNY 3,000,000
Paid-in capital
CNY 3,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Wholesale trade
Last approval date
2025-12-11
Recognitions
Micro and small enterprise

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.

Registration details (sample)

MarketIdentifierNameClass / date
CN桂械注准20242400280血红蛋白试纸(电化学法)Class II
CN桂械注准20232400142血糖质控液Class II
CN桂械注准20212400019血糖试纸(电化学法)Class II
CN桂械注准20212400018血红蛋白试纸(电化学法)Class II
EU06971913783714MINDMEDivd-annex-ii-list-b
EUD-697191378-TCTSHSACCU-ANSWERivd-devices-self-testing
EUD-697191378-UATSHPACCU-ANSWERivd-devices-self-testing
EUD-697191378-HTSKGACCU-ANSWERivd-devices-self-testing
UK53307Blood Glucose Test StripsIVD Devices for Self-Testing
UK62537Blood Glucose MetersIVD Annex II List B
UK57273Hemoglobin Test StripsIVD Devices for Self-Testing

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →