HomeChinaHEBEI HEALTHPLUS MEDICAL DEVICE CO.,LTD

HEBEI HEALTHPLUS MEDICAL DEVICE CO.,LTD

China · 邯郸
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000013062Unified social credit code 91130400665293311G

This company holds 4 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
4China registrations
Class I 3Class II 1
as of 2026-09-04
EUEuropean UnionEUDAMED
101UDI-DI device records
Class I 101
USUnited StatesFDA openFDA
18listed device types
Class I 18Class II 0Class III 0
plus 18 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class I 5
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered 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 Union102 raw hits, 1 excluded, 101 confirmed
United States18 registration records, 0 510(k), 0 PMA, 1 excluded
China4 certificates (Class III 0 / II 1 / I 3), as of 2026-09-04
United Kingdom5 confirmed, 0 excluded
Saudi Arabia4 confirmed, 0 excluded
Manufacturer names merged into this page: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD · Hebei Healthplus Medical device Co., Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000013062
EU authorised representative
KOMAS Medical Technology GmbH
UK responsible person
UK APLAN CORPORATION LTD
Unified social credit code
91130400665293311G
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
199
Annual revenue
RMB 100–500M
Product categories
康复 & 养老

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
2007-08-28
Registered capital
USD 16,000,000
Paid-in capital
USD 12,000,000
Legal form
Limited liability company (HK/Macao/Taiwan invested, not wholly owned, not wholly owned)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2024-08-28
Recognitions
National High-Tech EnterpriseTechnology-based SMESRDI SME

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 listed device types

showing 8 of 18
Exerciser, Non-Measuring 1Monitor, Bed Patient 1Bed, Patient Rotation, Manual 1Wheelchair, Mechanical 1Stand, Infusion 1Walker, Mechanical, Poly Vinyl Chloride (Pvc) 1Scale, Platform, Wheelchair 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1

Registration details (sample)

MarketIdentifierNameClass / date
CN冀械注准20192190188手动轮椅车Class II
CN冀邯械备20260017框式助行器Class I
CN冀邯械备20260016轮式助行器Class I
CN冀邯械备20260015医用拐Class I
EU06973222008212Class I
EU06973222008205Class I
EU06973222008113Class I
EU06973222008090Class I
UK31057Basic toilet seatClass I
UK41069Bath back rest / seatClass I
UK37951Foldable walkerClass I
SAME0000009993SFDAA00002Raised Toilet Seat
SAME0000009993SFDAA00004Shower Transfer Bench

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