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HEFEI MEYER OPTOELECTRONIC TECHNOLOGY INC.

✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000029043Unified social credit code 913401007199129080

This company holds 29 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Taiwan, Singapore, Australia — 6 overseas markets. EU UDI-DI records ≥8, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

29China registrations

Class I 9Class II 6Class III 14

as of 2026-09-04

EUEuropean UnionEUDAMED

≥8UDI-DI device records

Class I 3Class IIb 5

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

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class I 2Class IIb 2

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

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

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.

European Union427 raw hits, 292 excluded, 8 confirmed. Large result set — only the first 300 verified

United States1 registration records, 1 510(k), 0 PMA, 8 excluded

China29 certificates (Class III 14 / II 6 / I 9), as of 2026-09-04

United Kingdom4 confirmed, 3 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: HEFEI MEYER OPTOELECTRONIC TECHNOLOGY INC.

Regulatory identity

EU manufacturer SRN: CN-MF-000029043
EU authorised representative: MedPath GmbH
UK responsible person: MedPath Limited
Unified social credit code: 913401007199129080
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2000-03-03
Registered capital: CNY 882,228,900
Paid-in capital: CNY 882,228,900
Legal form: Joint-stock limited company (listed, natural-person invested or controlled)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-06-16
Recognitions: National High-Tech EnterpriseManufacturing Single ChampionGazelle enterpriseRecognised enterprise technology centreTechnology "Little Giant"Technology Innovation Demonstration EnterpriseInnovative enterpriseAbove-designated-size industrial enterprise
Listing: Listed on the A-share market

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.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263061825	移动式头部X射线计算机体层摄影设备	Class III
CN	国械注准20263011755	骨科手术导航定位设备	Class III
CN	国械注准20253061142	口腔颌面锥形束计算机体层摄影设备	Class III
CN	国械注准20253060862	口腔颌面锥形束计算机体层摄影设备	Class III
EU	06975066322103	Dental Cone-beam Computed Tomography	Class IIb
EU	06975066322097	Dental Cone-beam Computed Tomography	Class IIb
EU	06975066322080	Dental Cone-beam Computed Tomography	Class IIb
EU	06975066322066	Dental Cone-beam Computed Tomography	Class IIb
UK	63669	Intraoral Scanner	Class I
UK	63669	Intraoral Scanner TIP	Class I
UK	43369	2D Panoramic Dental Imaging System	Class IIb
US	K261748	Dental Cone-beam Computed Tomography (mDX-15P Series)	2026-07-23

HEFEI MEYER OPTOELECTRONIC TECHNOLOGY INC.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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