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Biomedical Srl

Italy · Firenze · www.biomedical-srl.com
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, United Kingdom, Brazil, Hong Kong, Israel, Russia — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class I 1Class IIa 2Class IIb 1
BRBrazilANVISA
17registered devices
Class II 17
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
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 2Class 2b 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 Union9,452 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States1 registration records, 0 510(k), 0 PMA, 335 excluded
United Kingdom4 confirmed, 50 excluded
Brazil17 confirmed, 61 excluded
Saudi Arabia0 confirmed, 5 excluded
Canada0 confirmed, 54 excluded
Manufacturer names merged into this page: X-BIOMEDICAL INC. · BIOMEDICAL SRL.

Regulatory identity

UK responsible person
MedEnvoy UK Limited
Exhibition record
CMEF 87th (Spring 2023, Shanghai)

Company information

Country
Italy
City
Firenze
Website
www.biomedical-srl.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiation TherapyTreatment planning systemsLaboratory, IVD & DiagnosticsPoint-of-care & near-patient testingMedical Devices & Clinical EquipmentSurgical systems & instruments

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

Legal name
BIOMEDICAL SPA
LEI
8156009046C2B0EE3006
Registration status
Active
Legal form
Società Per Azioni (SPA)
Incorporated
2008-06-19
Registered address
VIA PRA', 1/B, GENOVA, 16157
Registration authority
Business Register, no. 12235730152
Registry record updated
2026-02-12

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

Microscope, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
UK40783TATO 2Class IIb
UK40792TATOproClass IIa
UK42513TatoCartClass I
BR10289680203Cânula de estimulação e bloqueio BiomedicalClass II
BR10289680149Cânula para biópsia hepática segundo Menghini BiomedicalClass II
BR10289689007Máscara para ventilação em procedimentos endoscópicos JANUS 01Class II

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