HomeChinaShenzhen Roundwhale Technology Co., Ltd.

Shenzhen Roundwhale Technology Co., Ltd.

China · Shenzhen · www.roovjoy.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000021504

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Australia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
78UDI-DI device records
Class I 11Class IIa 67
USUnited StatesFDA openFDA
8listed device types
Class I 1Class II 7Class III 0
plus 9 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 2
BRBrazilANVISA
3registered devices
Class II 3
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
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
11active ARTG entries
Class I 3IIa 8
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 Union78 raw hits, 0 excluded, 78 confirmed
United States9 registration records, 7 510(k), 0 PMA
United Kingdom2 confirmed, 0 excluded
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD. · SHENZHEN ROUNDWHALE TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000021504
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Wellkang Ltd

Company information

Country
China
City
Shenzhen
Website
www.roovjoy.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.

FDA 510(k) clearances by year

22018 · K181688
12019 · K192087
22023 · K231440
22024 · K231423

FDA listed device types

Massager, Therapeutic, Electric 1Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Stimulator, Muscle, Powered 1Cable, Electrode 1Electrode, Cutaneous 1Interferential Current Therapy 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Stimulator, Nerve, Transcutaneous, For Pain Relief 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06971763600902Self-adhesive Electrode PadsClass I
EU06971763600087NEUROLOGICALPHYSIOTHERAPYDEVICES -ACCESSORIESClass I
EU06971763600094NEUROLOGICALPHYSIOTHERAPYDEVICES -ACCESSORIESClass I
EU06971763600100NEUROLOGICALPHYSIOTHERAPYDEVICES -ACCESSORIESClass I
UK35372Combo Electrotherapy DeviceClass IIa
UK46573Combo Electrotherapy DeviceClass IIa
USK231423Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)2024-01-22
USK232995Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe2024-01-11
USK231440Combo Electrotherapy Device2023-11-03
BR10410309026ELETRODO AUTOADESIVO BIOSTIMClass II
BR80284459003ELETRODO AUTOADESIVO ARKTUSClass II
BR10410309015Dispositivo de eletroterapia combinadoClass II

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