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BIOPSYBELL S.R.L.

Italy · Mirandola Modena

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Israel, Russia — 7 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

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 9Class II 7Class III 0

plus 15 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class II 14

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 II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

IIa 14Class Is (sterile) 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 2b 3

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.

United States15 registration records, 4 510(k), 0 PMA, 1 excluded

Brazil14 confirmed, 1 excluded

Manufacturer names merged into this page: BIOPSYBELL S.R.L.

FDA 510(k) clearances by year

12014 · K130616

12018 · K180315

12021 · K203397

12023 · K231340

FDA listed device types

showing 8 of 16

Brace, Drill 1Device, Percutaneous, Biopsy 1Spinal Channeling Instrument, Vertebroplasty 1Injector, Vertebroplasty (Does Not Contain Cement) 1Guide, Needle, Surgical 1Needle, Aspiration And Injection, Disposable 1Mixer, Cement, For Clinical Use 1Orthopedic Manual Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231340	Renova Spine Balloon Catheter	2023-10-30
US	K203397	Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm	2021-01-11
US	K180315	DISKOM	2018-03-26
BR	80285220008	CÂNULA DE BLOQUEIO DE CHIBELL	Class II
BR	81050760099	Kit Agulhas de Biópsia para Células Tronco Ósseas Mesenquimais Unlux B	Class II
BR	81050760112	Kit Lipo-Stem BPB Medica	Class II

BIOPSYBELL S.R.L.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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