HomeChinaXiamen Probtain Technology Group Co.

Xiamen Probtain Technology Group Co.

China · 厦门 · www.probtain.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000003329Unified social credit code 91350212MA333XCG9R

This company holds 27 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Saudi Arabia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
27China registrations
Class I 4Class II 23
as of 2026-09-04
EUEuropean UnionEUDAMED
9UDI-DI device records
Class I 9
USUnited StatesFDA openFDA
10listed device types
Class I 7Class II 3Class III 0
plus 12 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
10registered device records
Class I 10
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 Union9 raw hits, 0 excluded, 9 confirmed
United States12 registration records, 5 510(k), 0 PMA
China27 certificates (Class III 0 / II 23 / I 4), as of 2026-09-04
United Kingdom10 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000003329
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91350212MA333XCG9R
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
58
Annual revenue
RMB 100–500M
Website
www.probtain.com

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
2019-08-06
Registered capital
CNY 20,000,000
Paid-in capital
CNY 20,000,000
Legal form
Limited liability company (wholly owned by a natural-person-controlled corporation)
Industry classification
Research and experimental development
Last approval date
2025-06-10
Recognitions
National 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

12020 · K201893
12021 · K202954
32023 · K223401

FDA listed device types

showing 8 of 10
Mask, Surgical 1Gown, Surgical 1Gown, Isolation, Surgical 1Cap, Surgical 1Dress, Surgical 1Garment, Protective, For Incontinence 1Non-Surgical Gown 1Mask, Scavenging 1

Registration details (sample)

MarketIdentifierNameClass / date
CN闽械注准20262140168一次性使用无菌手术膜Class II
CN闽械注准20262140167一次性使用无菌手术包Class II
CN闽械注准20262140143一次性使用介入包Class II
CN闽械注准20262140142一次性使用无菌护理包Class II
EU06976323640527Class I
EU06976323640510Class I
EU06976323640503Class I
EU06976323640497Class I
UK35492Isolation clothingClass I
UK35492Isolation clothingClass I
UK47783Surgical drapeClass I
USK223401Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)2023-03-07
USK223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)2023-02-08
USK223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)2023-01-04
SAME0000018385SFDAA00001Single-use Surgical Mask

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