HomeChinaHenan Robestain Medical Products Co., Ltd.

Henan Robestain Medical Products Co., Ltd.

China · 新乡 · www.robestain.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000039804Unified social credit code 91410728594868869R

This company holds 39 NMPA certificates in China and has registrations in European Union, United States, Australia — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
39China registrations
Class I 14Class II 25
as of 2026-09-04
EUEuropean UnionEUDAMED
31UDI-DI device records
Class I 31
USUnited StatesFDA openFDA
5listed device types
Class I 3Class II 2Class III 0
plus 5 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
IIa 1Class Is (sterile) 4
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 Union31 raw hits, 0 excluded, 31 confirmed
United States5 registration records, 1 510(k), 0 PMA
China39 certificates (Class III 0 / II 25 / I 14), as of 2026-09-04
Manufacturer names merged into this page: HENAN ROBESTAIN MEDICAL PRODUCTS CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000039804
EU authorised representative
MedPath GmbH
Unified social credit code
91410728594868869R
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
2
Website
www.robestain.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
2012-04-24
Registered capital
CNY 21,000,000
Paid-in capital
CNY 21,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-07-18
Recognitions
Micro and small 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

12021 · K212925

FDA listed device types

Gown, Surgical 1Drape, Surgical, Exempt 1Non-Surgical Gown 1Dress, Surgical 1Accessory, Surgical Apparel 1

Registration details (sample)

MarketIdentifierNameClass / date
CN豫械注准20232140747医用防护组合包Class II
CN豫械注准20232140746一次性使用颅脑手术包Class II
CN豫械注准20232140745一次性使用四肢手术包Class II
CN豫械注准20232140744一次性使用心血管介入包Class II
EU06971604531396Disposable Surgical DrapesClass I
EU06971604531389Disposable Surgical DrapesClass I
EU06971604531372Disposable Surgical DrapesClass I
EU06971604531365Disposable Surgical DrapesClass I
USK212925Disposable Surgical Gown2021-12-13

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