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ATMOS Medizin Technik GmbH Co KG

Germany · Lenzkirch

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 3 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

14listed device types

Class I 10Class II 4Class III 0

plus 17 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

34registered imported devices

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

CACanadaMDALL

35active device licences

Class II 34Class III 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States17 registration records, 2 510(k), 0 PMA, 2 excluded

Saudi Arabia34 confirmed, 0 excluded

Canada35 confirmed, 0 excluded

Manufacturer names merged into this page: ATMOS MEDIZINTECHNIK GMBH & CO. KG · ATMOS MedizinTechnik GmbH & Co. KG · ATMOS Medizin Technik GmbH Co KG

FDA 510(k) clearances by year

12023 · K232015

12025 · K241799

FDA listed device types

showing 8 of 14

Laryngoscope, Nasopharyngoscope 1Nasopharyngoscope (Flexible Or Rigid) 1Colposcope (And Colpomicroscope), Exempt 1Pump, Portable, Aspiration (Manual Or Powered) 1Chair, Surgical, Ac-Powered 1Stimulator, Caloric-Water 1Stimulator, Caloric-Air 1Source, Carrier, Fiberoptic Light 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241799	ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C	2025-03-07
US	K232015	ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)	2023-08-03
SA	ME0000014997SFDAA00008	ATMOS Scope	—
SA	ME0000014997SFDAA00007	ATMOS iQam	—
CA	69171	LARYNGOSCOPES	Class II
CA	69295	BREATHING MASKS FOR RHINOMANOMETER 300	Class II
CA	69296	ZD SURGICAL SUCTION UNIT	Class II

ATMOS Medizin Technik GmbH Co KG

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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