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CAIRE Inc.

✓ Record-verifiedregistrations found in 11 marketsEU SRN US-MF-000013030Unified social credit code 91510100201954513W

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 11 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

84UDI-DI device records

Class IIa 84

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 33 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class IIa 5

BRBrazilANVISA

6registered devices

Class II 6

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

6active device licences

Class II 5Class III 1

28 including historic records

TWTaiwanTFDA

6valid device licences

Class II 6

SGSingaporeHSA SMDR

12device registrations

CLASS B 12

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IIa 1IIb 4

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 5

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.

European Union86 raw hits, 2 excluded, 84 confirmed

United States33 registration records, 7 510(k), 0 PMA, 2 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom5 confirmed, 1 excluded

Brazil6 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: CAIRE INC. · CAIRE INC, · CAIRE Inc.

Regulatory identity

EU manufacturer SRN: US-MF-000013030
EU authorised representative: MPS Medical Product Service GmbH
UK responsible person: Emergo Consulting (UK) Limited
Unified social credit code: 91510100201954513W
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 1987-10-12
Registered capital: CNY 12,000,000
Paid-in capital: CNY 12,000,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Other manufacturing
Last approval date: 2026-07-03
Recognitions: Micro and small enterpriseTechnology-based SMEInnovative SME

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

11995 · K952268

12001 · K013251

12005 · K050153

12008 · K080023

22012 · K120785

12025 · K250671

FDA listed device types

Conserver, Oxygen 1Generator, Oxygen, Portable 1Unit, Liquid-Oxygen, Portable 1Flowmeter, Calibration, Gas 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	M766AS092210	AirSEP AS-N	Class IIa
EU	M766AS107210	AirSEP AS-L	Class IIa
EU	M766AS106210	AirSEP AS-K	Class IIa
EU	M766AS105210	AirSEP AS-J	Class IIa
UK	61365	Flowmeter, SureFlow	Class IIa
UK	31321	Eclipse	Class IIa
UK	35910	Helios	Class IIa
US	K250671	FreeStyle Comfort (AS200 / FreeStyle Comfort)	2025-07-11
US	K120785	OMNI 3 OXYGEN SYSTEM	2012-10-25
US	K121167	CAIRE COMPANION 5 OXYGEN CONCENTRATOR	2012-05-02
BR	80047300071	EQUIPAMENTO RESPIRATORIO PORTATIL DE OXIGENIO LIQUIDO	Class II
BR	80047300310	EQUIPAMENTO RESPIRATÓRIO DE OXIGÊNIO LIQUIDO	Class II
BR	80102519096	Concentrador de Oxigênio	Class II
CA	4742	COMPANION HIGH PRESSURE REGULATORS	Class II
CA	61199	OXICLIP PC20 PERSONAL OXYGEN CONSERVER	Class II
CA	62484	LIFESTYLE	Class II