Home›USA›SPIRACLE TECHNOLOGY, LLC

SPIRACLE TECHNOLOGY, LLC

USA · Los Alamitos

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 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

9listed device types

Class I 5Class II 4Class III 0

plus 11 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

10active device licences

Class II 10

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIa 2IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

pendingnot queried

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 States11 registration records, 4 510(k), 0 PMA

Canada10 confirmed, 0 excluded

Manufacturer names merged into this page: SPIRACLE TECHNOLOGY · SPIRACLE TECHNOLOGY, LLC

FDA 510(k) clearances by year

11996 · K953349

11997 · K963755

21998 · K982225

FDA listed device types

showing 8 of 9

Laryngoscope, Rigid 1Flowmeter, Calibration, Gas 1Mask, Oxygen, Non-Rebreathing 1Regulator, Pressure, Gas Cylinder 1Catheters, Suction, Tracheobronchial 1Valve, Non-Rebreathing 1Blood Pressure Cuff 1Ventilator, Emergency, Manual (Resuscitator) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K982225	SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504	1998-10-28
US	K973347	TSX PRM PULMONARY RESUSCITATION MONITOR	1998-07-23
US	K963755	SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR	1997-04-08
CA	80521	FERNO2 MVP (MANUAL VACUUM PUMP)	Class II
CA	80522	FERNO2 LARYNGOSCOPE KIT	Class II
CA	80528	FERNO2 OXYGEN PRESSURE AND/OR FLOW REGULATORS	Class II

SPIRACLE TECHNOLOGY, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies