HomeChinaAnhui Bytech Medical Supplies C0.,Ltd.

Anhui Bytech Medical Supplies C0.,Ltd.

China · 宿州
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000011490

This company holds 1 NMPA certificates in China and has registrations in European Union, United States, Brazil, Saudi Arabia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
1China registrations
Class I 1
as of 2026-09-04
EUEuropean UnionEUDAMED
8UDI-DI device records
Class I 8
USUnited StatesFDA openFDA
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class I 1
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 Union36 raw hits, 28 excluded, 8 confirmed
United States0 registration records, 2 510(k), 0 PMA, 3 excluded
China1 certificates (Class III 0 / II 0 / I 1), as of 2026-09-04
United Kingdom0 confirmed, 2 excluded
Brazil1 confirmed, 1 excluded
Saudi Arabia1 confirmed, 2 excluded
Manufacturer names merged into this page: ANHUI BYTECH MEDICAL SUPPLIES CO., LTD&#8194. · Anhui Bytech Medical Supplies Co., Ltd.

Regulatory identity

EU manufacturer SRN
CN-MF-000011490
EU authorised representative
SUNGO Europe B.V.
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
24

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
2017-08-09
Registered capital
CNY 58,000,000
Paid-in capital
CNY 58,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-12-25
Recognitions
National High-Tech EnterpriseSRDI SMERecognised enterprise technology centre

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

12021 · K201504
12022 · K222442

Registration details (sample)

MarketIdentifierNameClass / date
CN皖宿械备20190006医用检查手套Class I
EU06974034769896Class I
EU06974034769872Class I
EU06974034769889Class I
EU06974034769865Class I
USK222442DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)2022-09-28
USK201504Single-use medical poly (vinyl chloride) examination glove2021-05-10
BR81818100017Luva NitrílicaClass I
SAME0000001076SFDAA00010bytech

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