HomeChinaWELLMED DENTAL MEDICAL SUPPLY CO., LTD.

WELLMED DENTAL MEDICAL SUPPLY CO., LTD.

China · 深圳 · www.wellmeddental.com/cn
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000003243Unified social credit code 91440300326551814F

This company holds 2 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Saudi Arabia, Taiwan, Australia, Israel — 7 overseas markets. EU UDI-DI records ≥113, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
2China registrations
Class I 2
as of 2026-09-04
EUEuropean UnionEUDAMED
≥113UDI-DI device records
Class I 113
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
37listed device types
Class I 31Class II 5Class III 0unclassified 1
plus 35 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
11registered device records
Class I 11
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
31registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
47active ARTG entries
Class I 47
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 Union3,314 raw hits, 187 excluded, 113 confirmed. Large result set — only the first 300 verified
United States35 registration records, 3 510(k), 0 PMA, 1 excluded
China2 certificates (Class III 0 / II 0 / I 2), as of 2026-09-04
United Kingdom11 confirmed, 0 excluded
Brazil0 confirmed, 6 excluded
Saudi Arabia31 confirmed, 1 excluded
Manufacturer names merged into this page: Wellmed Dental Medical Supply Co., Ltd · Wellmed Dental Medical Supply Co Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000003243
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91440300326551814F
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
18
Annual revenue
RMB 50–100M
Website
www.wellmeddental.com/cn

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

Registration status
Active
Incorporated
2015-01-30
Registered capital
CNY 1,000,000
Paid-in capital
CNY 75,000
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-06-08
Recognitions
Micro and small enterprise

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

12022 · K222697
12024 · K242435
12025 · K243721

FDA listed device types

showing 8 of 37
Cap, Surgical 1Gauze / Sponge,Nonresorbable For External Use 1Evacuator, Oral Cavity 1Aligner, Bracket, Orthodontic 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Toothbrush, Manual 1Bedding, Disposable, Medical 1Unit, Syringe, Air And/Or Water 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤深械备20200754号医用隔离面罩Class I
CN粤深械备20200753号隔离衣Class I
EU16974608657168Class I
EU06974608657161Class I
EU06974608656997Class I
EU06974608658069Class I
UK58232Cotton RollsClass I
UK45131Air Water Syringe TipsClass I
UK16350Disposable Bite TraysClass I
USK243721Self Sealing Sterilization Pouches2025-04-25
USK242435Dental Barrier and Sleeves2024-10-18
USK222697Disposable Medical Face Mask (DF3-001)2022-11-04
SAME0000008811SFDAA00012Turbine Motor Sleeves
SAME0000008811SFDAA00009Digital X-Ray Sensor Sleeves

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