HomeChinaKOOLCARE TECHNOLOGY CO., LTD.

KOOLCARE TECHNOLOGY CO., LTD.

China · Xuzhou · www.koolcare.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000017687Unified social credit code 91310117MA1J1EYR74

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia — 6 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
151UDI-DI device records
Class I 25Class IIa 126
USUnited StatesFDA openFDA
6listed device types
Class I 6Class II 0Class III 0
plus 6 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
7registered device records
Class I 3Class IIa 4
BRBrazilANVISA
2registered devices
Class I 2
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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
12active ARTG entries
Class I 7IIa 5
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 Union151 raw hits, 0 excluded, 151 confirmed
United States6 registration records, 0 510(k), 0 PMA, 1 excluded
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
United Kingdom7 confirmed, 0 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: KOOLCARE TECHNOLOGY CO., LTD · KOOLCARE TECHNOLOGY CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000017687
EU authorised representative
Prolinx GmbH
UK responsible person
PROLINX GLOBAL LTD
Unified social credit code
91310117MA1J1EYR74
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Xuzhou
Social-insurance enrolees
24
Annual revenue
RMB 10–30M
Website
www.koolcare.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
2016-06-29
Registered capital
CNY 1,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Professional technical services
Last approval date
2020-08-06
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.

FDA listed device types

Joint, Knee, External Brace 1Orthosis, Lumbar 1Pack, Hot Or Cold, Disposable 1Pack, Heat, Moist 1Pack, Hot Or Cold, Reusable 1Joint, Ankle, External Brace 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06974423593125BIPA BI LFE WärmegürtelClass IIa
EU06974423593002BIPA BI LFE WärmegürtelClass IIa
EU06974423590162Heldenwerk GmbHClass I
EU16974423593184Class IIa
UK46556Cooling patchesClass I
UK60790Instant cold packsClass IIa
UK37697Heat wrapsClass IIa
BR82805660035GELCAREClass I
BR82805660021LINHA GELCAREClass I

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