HomeChinaLongfian Scitech Co., Ltd

Longfian Scitech Co., Ltd

China · Baoding Hebei · www.longfian.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000028163Unified social credit code 91130605695886804B

This company holds 4 NMPA certificates in China and has registrations in European Union, United States, Brazil, Singapore, South Korea, Australia, Israel, Russia — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
5UDI-DI device records
Class IIa 5
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 4 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
2registered devices
Class II 2
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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
11registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 4
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 Union5 raw hits, 0 excluded, 5 confirmed
United States4 registration records, 3 510(k), 0 PMA
China4 certificates (Class III 0 / II 4 / I 0), as of 2026-09-04
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: LONGFIAN SCITECH CO., LTD. · LONGFIAN SCITECH CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000028163
EU authorised representative
Obelis s.a.
Unified social credit code
91130605695886804B
Exhibition record
Rehab & Elderly Care Expo (Spring 2024, Shanghai) · Rehab & Elderly Care Expo (Spring 2026, Shanghai)

Company information

Country
China
City
Baoding Hebei
Social-insurance enrolees
133
Annual revenue
over RMB 500M
Website
www.longfian.com
Product categories
Integrated Care, Rehabilitation & HomecareHomecare, long-term care & ageing

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Incorporated
2009-10-26
Registered capital
CNY 10,000,000
Legal form
Limited liability company (natural-person invested or controlled)

Business registration data from Tianyancha, as of 2026-09-01. 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

12014 · K131968
12022 · K213210
12025 · K243833

FDA listed device types

Flowmeter, Tube, Thorpe, Back-Pressure Compensated 1Generator, Oxygen, Portable 1

Registration details (sample)

MarketIdentifierNameClass / date
CN冀械注准20252080187医用分子筛制氧机Class II
CN冀械注准20222080375医用分子筛制氧机Class II
CN冀械注准20222080051医用分子筛制氧机Class II
CN冀械注准20212080388医用分子筛制氧机Class II
EU06934726614118Class IIa
EU06934726614064Class IIa
EU06934726614088Class IIa
EU06934726614071Class IIa
USK243833Portable oxygen concentrator (JAY-1000P)2025-09-29
USK213210Oxygen Concentrator, Model JAY-5AW2022-12-08
USK131968LONGFIAN OXYGEN CONCENTRATOR2014-09-05
BR10317709002CONCENTRADOR DE OXIGÊNIO PORTÁTILClass II
BR10317700025CONCENTRADOR DE OXIGENIOClass II

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