HomeChinaDalian Labtek Science and Development Co., Ltd

Dalian Labtek Science and Development Co., Ltd

China · Dalian · www.labtek-med.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000042341Unified social credit code 91210213792008958K

This company holds 12 NMPA certificates in China and has registrations in European Union, United States, Brazil, Australia, Israel, Russia — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
12China registrations
Class I 5Class II 7
as of 2026-09-04
EUEuropean UnionEUDAMED
41UDI-DI device records
Class I 34Class IIa 7
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 3 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
2registered devices
Class I 1Class II 1
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
4active ARTG entries
Class I 1IIa 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 Union285 raw hits, 244 excluded, 41 confirmed
United States3 registration records, 3 510(k), 0 PMA
China12 certificates (Class III 0 / II 7 / I 5), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: DALIAN LABTEK SCIENCE & DEVELOPMENT CO LTD · DALIAN LABTEK SCIENCE & DEVELOPMENT CO. LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000042341
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
91210213792008958K
Exhibition record
Rehab & Elderly Care Expo (Spring 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Dalian
Social-insurance enrolees
49
Annual revenue
RMB 10–30M
Website
www.labtek-med.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationPhysiotherapy equipment

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
2006-09-04
Registered capital
CNY 3,000,000
Paid-in capital
CNY 1,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-09-12
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.

FDA 510(k) clearances by year

12012 · K121718
12013 · K123830
12022 · K213313

FDA listed device types

Sleeve, Limb, Compressible 1

Registration details (sample)

MarketIdentifierNameClass / date
CN辽械注准20212080002一次性咽喉手术支架Class II
CN辽械注准20192060049红外荧光定位观察仪Class II
CN辽械注准20182060001可视支撑喉镜系统Class II
CN辽械注准20162090212动静脉脉冲气压治疗仪Class II
EU06971599072348sequential compression sleevesClass I
EU06971599072331sequential compression sleevesClass I
EU06971599072324sequential compression sleevesClass I
EU06971599072317sequential compression sleevesClass I
USK213313Veinoflow SCD (Model: LBTK-M-I 5006)2022-02-09
USK123830INTERMITTENT PNEUMATIC COMPRESSION DEVICE2013-08-16
USK121718A-V FOOT PUMP2012-08-17
BR80050820009Veinoflow SCDClass II
BR80050820005PERNEIRA SCDClass I

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