HomeChinaDOUBLE CARE MEDICAL TECHNOLOGY CO.,LTD

DOUBLE CARE MEDICAL TECHNOLOGY CO.,LTD

China · 惠州 · website:www.doublecare-med.com
✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000009048Unified social credit code 91441322576447374K

This company holds 10 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Russia — 10 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
10China registrations
Class I 9Class II 1
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class IIa 1Class IIb 89Class III 210
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
33listed device types
Class I 22Class II 11Class III 0
plus 55 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
42registered device records
Class I 9Class IIb 33
BRBrazilANVISA
64registered devices
Class I 48Class II 16
76 including historic records
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
14valid device licences
Class I 12Class II 2
SGSingaporeHSA SMDR
7device registrations
CLASS C 7
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
9active ARTG entries
Class I 2IIb 7
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
13active registrations
Class 1 3Class 2a 2Class 2b 7Class 3 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 Union658 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States55 registration records, 12 510(k), 0 PMA, 8 excluded
China10 certificates (Class III 0 / II 1 / I 9), as of 2026-09-04
United Kingdom42 confirmed, 0 excluded
Brazil64 confirmed, 3 excluded
Saudi Arabia1 confirmed, 2 excluded
Manufacturer names merged into this page: DOUBLE CARE MEDICAL TECHNOLOGY CO.,LTD. · Double Medical Technology Inc. · DOUBLE MEDICAL TECHNOLOGY INC · Double Care Medical Technology Co., Ltd.

Regulatory identity

EU manufacturer SRN
CN-MF-000009048
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91441322576447374K
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
92
Annual revenue
RMB 30–50M
Website
website:www.doublecare-med.com
Product categories
康复 & 养老医用康复器械

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
2011-06-09
Registered capital
CNY 2,000,000
Paid-in capital
CNY 1,300,000
Legal form
Limited liability company (wholly owned by a natural person)
Industry classification
Other manufacturing
Last approval date
2020-05-06
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEInnovative 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

12016
22018
22022 · K221221
52023 · K233078
12024 · K242348
12025 · K252729

FDA listed device types

showing 8 of 33
Cap, Surgical 1Template 1Crutch 1Bed, Manual 1Exerciser, Non-Measuring 1Orthosis, Limb Brace 1Stand, Infusion 1Aid, Transfer 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20182190280手动轮椅车Class II
CN粤惠械备20260024手动轮椅车Class I
CN粤惠械备20240051手动病床Class I
CN粤惠械备20210071号助行器Class I
EU06902139006400Class IIb
EU06902139006394Class IIb
EU06902139006387Class IIb
EU06902139006370Class IIb
UK31115CrutchClass I
UK37961Walking frameClass I
UK31113CrutchClass I
USK252729Universal Spinal System2025-11-18
USK242348Locking Screw,CoCrMo2024-12-04
USK233078Posterior Cervical Spine System2023-11-22
BR82958150007Instrumentais Cirúrgicos em Aluminio para Implantes de Coluna - DMClass I
BR82958150008Instrumentais Cirúrgicos em Inox para Implantes de Coluna - DMClass I
BR82958150009Fixador Externo Dinâmico - DMClass I
SAME0000011675SFDAA00001WHEELCHAIR

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