HomeChinaHENAN HUIBO MEDICAL CO.,LTD

HENAN HUIBO MEDICAL CO.,LTD

China · 南阳 · www.hbmed.cn
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000013580Unified social credit code 91411300767846255L

This company holds 82 NMPA certificates in China and has registrations in European Union, United States, Brazil, Saudi Arabia, South Korea, Australia, Israel — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
82China registrations
Class I 19Class II 56Class III 5
as of 2026-09-04
EUEuropean UnionEUDAMED
78UDI-DI device records
Class I 78
USUnited StatesFDA openFDA
17listed device types
Class I 13Class II 3Class III 0unclassified 1
plus 18 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
4registered devices
Class I 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered 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
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
Class I 3
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 Union78 raw hits, 0 excluded, 78 confirmed
United States18 registration records, 1 510(k), 0 PMA
China82 certificates (Class III 5 / II 56 / I 19), as of 2026-09-04
Brazil4 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: HENAN HUIBO MEDICAL CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000013580
EU authorised representative
SUNGO Europe B.V.
Unified social credit code
91411300767846255L
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
141
Annual revenue
RMB 100–500M
Website
www.hbmed.cn
Product categories
注输、护理和防护器械输血、透析和体外循环器械

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
2004-11-10
Registered capital
CNY 98,000,000
Paid-in capital
CNY 97,992,275
Legal form
Joint-stock limited company (unlisted)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-05-30
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMERecognised enterprise technology centreAbove-designated-size industrial enterprise
Listing
Listed on the NEEQ

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 · K202842

FDA listed device types

showing 8 of 17
Orthosis, Lumbar 1Silicone Hydrogel For Scar Management 1Pack, Hot Or Cold, Disposable 1Non-Surgical Gown 1Expander, Surgical, Skin Graft 1Mask, Scavenging 1Joint, Ankle, External Brace 1Dressing, Compression 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243142585聚氨酯泡沫敷料Class III
CN国械注准20243100484富血小板血浆制备器Class III
CN国械注准20233141040聚氨酯封闭式负压引流套装Class III
CN国械注准20213141047水胶体敷料Class III
EU06936943495617Medical Silicone Gel DressingClass I
EU06936943474384Medical Silicone Gel DressingClass I
EU06936943474391Medical Silicone Sheet Dressing (Light&Clear)Class I
EU06936943476371Medical Silicone Sheet Dressing (Light&Clear)Class I
USK202842Medical surgical mask2021-11-26
BR81547300009VARIPRESS MEIAS COMPRESSIVASClass I
BR81547300003Varipress Meias CompressivasClass I
BR81547300004RESPIRADOR FILTRANTE - PFF2Class I
SAME0000015811SFDAA00001KN95 Respiratory Protective Mask
SAME0000015811SFDAA00002Vitacom Pure silicone scar gel

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