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THERMOGENESIS CORPORATION

USA · Rancho Cordova

✓ Record-verifiedregistrations found in 7 markets

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

3listed device types

Class I 1Class II 2Class III 0

plus 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

8active device licences

Class II 5Class III 3

12 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 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 States5 registration records, 3 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: ThermoGenesis Corp. · THERMOGENESIS CORP · THERMOGENESIS CORP. · THERMOGENESIS CORPORATION

FDA 510(k) clearances by year

11996 · K955282

12007 · K071126

12008 · K081345

FDA listed device types

Cord Blood Processing System And Storage Container 1Refrigerator, Freezer, Blood Storage 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K081345	AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)	2008-07-10
US	K071126	CRYOSEAL FS APPLICATOR SYSTEM	2007-08-16
US	K955282	THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS	1996-05-06
BR	10234400061	SISTEMA BIOARCHIVE - SISTEMA FECHADO DE LN2 PARA CONGELAMENTO DE AMOST	Class II
BR	10234400065	SISTEMA ULTRA RÁPIDO PARA CONGELAMENTO DE HEMOCOMPONENTES MICROCASCADE	Class II
CA	2882	CRYOSEAL SYSTEM	Class III
CA	82417	THROMBIN PROCESSING DEVICE (TPD)	Class III
CA	82418	CRYOSEAL FS SYSTEM	Class III

THERMOGENESIS CORPORATION

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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