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P&N Technology(Xiamen) Co., Ltd.

China · 厦门市

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000022723Unified social credit code 91350200051194108T

This company has registrations in European Union, United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥42, the first 300 verified individually. 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

≥42UDI-DI device records

Class I 33Class IIa 9

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

100listed device types

Class I 77Class II 20Class III 0unclassified 3

plus 189 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

61registered devices

Class I 12Class II 49

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

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Manufacturing 1

AUAustraliaTGA ARTG

11active ARTG entries

Class I 5IIa 6

HKHong KongMDACS

1valid listings

IVD C 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

13active registrations

Class 1 4Class 2a 6Class 2b 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.

European Union7,448 raw hits, 58 excluded, 42 confirmed. Large result set — only the first 300 verified

United States189 registration records, 20 510(k), 0 PMA, 122 excluded

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

Brazil61 confirmed, 28 excluded

Saudi Arabia3 confirmed, 11 excluded

Canada0 confirmed, 14 excluded

Manufacturer names merged into this page: AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD · XIAMEN FUYUANDA OPTICAL TECHNOLOGY CO., LTD. · HUILING (XIAMEN) MEDICAL TECHNOLOGY CO., LTD. · XIAMEN JS POLARIZERS TECHNOLOGY CO., LTD. · XIAMEN HIGH TOP ELECTRONIC TECHNOLOGY CO., LTD. · XIAMEN YUEYA TECHNOLOGY CORPORATION LIMITED

Regulatory identity

EU manufacturer SRN: CN-MF-000022723
EU authorised representative: Lotus NL B.V.
Unified social credit code: 91350200051194108T

Business registration

Registration status: Active
Incorporated: 2012-11-13
Registered capital: CNY 17,000,000
Paid-in capital: CNY 17,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Computer, communications and other electronic equipment
Last approval date: 2022-03-15
Recognitions: Micro and small enterpriseNational High-Tech Enterprise

Business registration data from Tianyancha, as of 2026-09-02. 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

12019

32020

22021

12022

32023

32024

22025

52026

FDA listed device types

showing 8 of 100

Sleeve, Limb, Compressible 1Bed, Ac-Powered Adjustable Hospital 1Mask, Surgical 1Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Pad, Heating, Powered 1Gown, Isolation, Surgical 1Massager, Powered Inflatable Tube 1Mattress, Air Flotation, Alternating Pressure 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06941812579282	Bone Mill Guide,φ3.0mm	Class IIa
EU	06973122434999	Positioning Rod	Class IIa
EU	06941812523612	Bone Condenser	Class IIa
EU	06973122433022	Machine Screwdriver,28mm	Class IIa
US	K252853	CAD - Lower GI (EC07-01)	2026-08-05
US	K260529	Air Compression Massager (HY-1165)	2026-07-27
US	K260948	Air Compression Massager (EP30B001 I)	2026-07-24
BR	81504799258	Curativo Líquido	Class II
BR	81325999034	Catéter de sucção descartável	Class II
BR	81325999035	Mascara de Ar Laríngea	Class II
SA	ME0000018385SFDAA00001	Single-use Surgical Mask	—
SA	ME0000007145SFDAA00001	Electric lift transfer chair	—