HomeChinaGuangzhou ORCL Medical Co.,Ltd.

Guangzhou ORCL Medical Co.,Ltd.

China · 广州 · www.orcl-medical.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000039222Unified social credit code 91440115562251696E

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 I 10Class II 9
as of 2026-09-04
EUEuropean UnionEUDAMED
72UDI-DI device records
Class I 9Class IIa 63
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
19registered device records
Class I 1Class IIa 18
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 Union72 raw hits, 0 excluded, 72 confirmed
China19 certificates (Class III 0 / II 9 / I 10), as of 2026-09-04
United Kingdom19 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN
CN-MF-000039222
EU authorised representative
Wellkang Ltd
UK responsible person
Wellkang Ltd
Unified social credit code
91440115562251696E
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
47
Annual revenue
RMB 30–50M
Website
www.orcl-medical.com
Product categories
手术室及急救医用耗材呼吸、麻醉和急救器械注输、护理和防护器械

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
2010-08-31
Registered capital
CNY 6,000,000
Paid-in capital
CNY 6,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2020-05-26
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20242021013一次性使用包茎包皮扩张器Class II
CN粤械注准20222140617一次性使用导尿包Class II
CN粤械注准20222140291一次性使用硅胶导尿管Class II
CN粤械注准20222020124一次性使用气管插管导丝Class II
EU06972745363273Tracheostomy TubeClass IIa
EU06972745360548Reinforced Endotracheal TubeClass IIa
EU06972745360531Reinforced Endotracheal TubeClass IIa
EU06972745360524Reinforced Endotracheal TubeClass IIa
UK10749Suction TubeClass IIa
UK46232Air Cushion maskClass IIa
UK37469Intubating StyletClass IIa

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