HomeChinaShenzhen Edge Medical Co., Ltd.

Shenzhen Edge Medical Co., Ltd.

China · 深圳 · www.edgemed.cn
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000039045Unified social credit code 91440300MA5EH2LU6N

This company holds 16 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Singapore, South Korea, Australia, Hong Kong, Russia — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
16China registrations
Class II 11Class III 5
as of 2026-09-04
EUEuropean UnionEUDAMED
131UDI-DI device records
Class I 36Class IIa 50Class IIb 45
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
16registered device records
Class I 7Class IIa 5Class IIb 3System or Procedure Pack 1
BRBrazilANVISA
0registered devices
1 including historic records
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
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
18active ARTG entries
Class I 6IIa 5IIb 4Class Is (sterile) 3
HKHong KongMDACS
3valid listings
Class III 3
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2b 1
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 Union172 raw hits, 41 excluded, 131 confirmed
United States0 registration records, 1 510(k), 0 PMA, 22 excluded
China16 certificates (Class III 5 / II 11 / I 0), as of 2026-09-04
United Kingdom16 confirmed, 10 excluded
Brazil0 confirmed, 2 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: SHENZHEN EDGE MEDICAL CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000039045
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
WISELINK MEDICAL (UK) LIMITED
Unified social credit code
91440300MA5EH2LU6N
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
522
Annual revenue
under RMB 5M
Website
www.edgemed.cn
Product categories
机器人

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
2017-05-04
Registered capital
CNY 360,000,000
Paid-in capital
CNY 359,999,960
Legal form
Joint-stock limited company (foreign-invested, listed)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-07-29
Recognitions
National High-Tech EnterpriseTechnology-based SMESRDI SMEInnovative SMEAbove-designated-size industrial enterprise
Listing
Listed in Hong Kong

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

12014 · K141958

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253060450支气管镜操作控制系统用支气管镜Class III
CN国械注准20253012667一次性使用超声软组织手术刀头Class III
CN国械注准20253010298支气管镜操作控制系统Class III
CN国械注准20233011753腹腔内窥镜单孔手术系统Class III
EU06975070993641Enhanced ForcepsClass IIa
EU06942854300193Zange, verst?rkt, bipolar Class IIb
EU06942854300094Zange, verst?rkt, bipolar Class IIb
EU06942854300186Zange, bipolarClass IIb
UK47487Bipolar energy instrument cordClass I
UK35507Light Guide BundlesClass I
UK12143Sterilization TrayClass I
USK141958ERB ENDORECTAL BALLOON2014-11-18

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