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Home›HUMAN BRAIN WAVE SRL

HUMAN BRAIN WAVE SRL

✓ Record-verifiedregistrations found in 12 marketsEU SRN IT-MF-000010074

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
3UDI-DI device records
Class I 3
USUnited StatesFDA openFDA
5listed device types
Class I 5Class II 0Class III 0
plus 5 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class I 2Class IIa 1
BRBrazilANVISA
17registered devices
Class I 10Class II 7
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1IIa 1
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 Union130 raw hits, 127 excluded, 3 confirmed
United States5 registration records, 0 510(k), 0 PMA, 23 excluded
United Kingdom3 confirmed, 7 excluded
Brazil17 confirmed, 1 excluded
Saudi Arabia2 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: HUMAN BRAIN WAVE SRL · human brain wave srl · Human Brain Wave S.r.l

Regulatory identity

EU manufacturer SRN
IT-MF-000010074
UK responsible person
yoursciencebc limited
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Employees
10–50
Annual revenue
RMB 100–500M

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 listed device types

Accessory, Surgical Apparel 1Burr, Orthopedic 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Expander, Surgical, Skin Graft 1Bone Mill 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08058481670153N4SA EVOClass I
EU08058481670146—Class I
EU08058481670016RIGENERA MACHINEClass I
UK33541rechargeable SicurdrillClass I
UK35134RIGENERACONS-ADIPECONS-KITClass IIa
UK64392Rigenera machineClass I
BR82919040001Tissue Kit-SClass I
BR82919040002KIT RIGENERA TISSUEClass I
BR80047300890Rigenera machine N4SA EVOClass I
SAME0000020778SFDAA00001N4SA—
SAME0000013277SFDAA00002Rechargeable Sicurdrill—

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