HomeChinaHaiyan Kangyuan Medical Instrument Co.,Ltd.

Haiyan Kangyuan Medical Instrument Co.,Ltd.

China · 嘉兴 · www.zjkyyl.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000001532Unified social credit code 91330424779353407P

This company holds 18 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, South Korea, Australia, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
18China registrations
Class II 18
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class IIa 147Class IIb 153
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
17listed device types
Class I 15Class II 2Class III 0
plus 18 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
15registered device records
Class IIa 13Class IIb 2
BRBrazilANVISA
31registered devices
Class II 31
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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
2active ARTG entries
IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 Union440 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States18 registration records, 0 510(k), 0 PMA, 1 excluded
China18 certificates (Class III 0 / II 18 / I 0), as of 2026-09-04
United Kingdom15 confirmed, 0 excluded
Brazil31 confirmed, 0 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: HAIYAN KANGYUAN MEDICAL INSTRUMENT CO.,LTD. · HAIYAN KANGYUAN MEDICAL INSTRUMENT CO.,LTD · HAIYAN KANGYUAN MEDICAL INSTRUMENT CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000001532
EU authorised representative
Eunitor GmbH
UK responsible person
MedPath Limited
Unified social credit code
91330424779353407P
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
263
Annual revenue
RMB 100–500M
Website
www.zjkyyl.com
Product categories
注输、护理和防护器械呼吸、麻醉和急救器械医用成像器械

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
2005-08-11
Registered capital
CNY 10,080,000
Paid-in capital
CNY 10,080,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2023-12-19
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SMERecognised enterprise technology centre

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 17
Catheter, Straight 1Catheter, Retention Type, Balloon 1Accessory, Surgical Apparel 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Collector, Urine, Powered, Non Indwelling Catheter 1Connector, Airway (Extension) 1Non-Surgical Gown 1Cannula, Nasal, Oxygen 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20202141356一次性使用医用口罩Class II
CN浙械注准20202140897一次性使用无菌测温导尿管Class II
CN浙械注准20192140294一次性使用硅胶导尿管Class II
CN浙械注准20182020292一次性使用输尿管导引鞘Class II
EU06948097050734Class IIb
EU06948097050727Class IIb
EU06948097050710Class IIb
EU06948097050703Class IIb
UK10749Suction Catheters for Single UseClass IIa
UK10749Sterile Suction Catheters for Single UseClass IIa
UK46967Endotracheal Tubes for Single UseClass IIa
BR80082919080CATETER FOLEY SILFLOW TAIMINClass II
BR10297029008Sonda Laringea Tipo máscara em PVC BCI MedicalClass II
BR81955459010SONDA NASOGASTRICO/ ENTERAL -ARIAClass II

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