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CELLAVISION, INC.

Sweden · Jupiter

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, 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

4listed device types

Class I 2Class II 2Class III 0

plus 8 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 1Class II 7

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

2active device licences

Class II 2

7 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

IVD Class 1 9

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

15registrations

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.

United States8 registration records, 7 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: CELLAVISION AB · CELLAVISION, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200595	CellaVision DC-1, CellaVision DC-1 PPA	2020-10-16
US	K171315	Advanced RBC Application	2017-08-01
US	K102778	CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION	2011-09-16
BR	10347320336	CellaVision DC-1	Class II
BR	10345169004	Cellavision Remote Review Software	Class I
BR	80146502303	Família de Instrumentos CellaVision	Class II
CA	691	MICR021 SYSTEM	Class II
CA	90120	CELLAVISION IMAGE CAPTURE SYSTEM	Class II

CELLAVISION, INC.

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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