HomeChinaZHANGJIAGANG XIEHE IMPORT&EXPORT CO.,LTD

ZHANGJIAGANG XIEHE IMPORT&EXPORT CO.,LTD

China · Zhangjiagang Jiangsu · www.xieeh.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000008449Unified social credit code 91320582781278282P

This company holds 19 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Saudi Arabia — 4 overseas markets. EU UDI-DI records ≥13, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
19China registrations
Class I 19
as of 2026-09-04
EUEuropean UnionEUDAMED
≥13UDI-DI device records
Class I 13
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
11listed device types
Class I 9Class II 2Class III 0
plus 11 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
6registered device records
Class I 6
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
5registered 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 Union1,168 raw hits, 287 excluded, 13 confirmed. Large result set — only the first 300 verified
United States11 registration records, 0 510(k), 0 PMA
China19 certificates (Class III 0 / II 0 / I 19), as of 2026-09-04
United Kingdom6 confirmed, 2 excluded
Saudi Arabia5 confirmed, 0 excluded
Manufacturer names merged into this page: Zhangjiagang Xiehe Medical Apparatus & Instruments Co., Ltd. · ZHANGJIAGANG XIEHE MEDICAL APPARATUS & INSTRUMENTS CO. LTD · Zhangjiagang Xiehe Import and Export Co, Ltd · Zhangjiagang Xiehe Medical Apparatus&Instrument Co., Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000008449
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91320582781278282P
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Zhangjiagang Jiangsu
Social-insurance enrolees
87
Annual revenue
RMB 50–100M
Website
www.xieeh.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentEmergency, Rescue & Disaster Medicine

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
2005-11-16
Registered capital
CNY 5,000,000
Paid-in capital
CNY 500,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2020-03-25
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 listed device types

showing 8 of 11
Stretcher, Hand-Carried 1Orthosis, Truncal/Orthosis, Limb 1Accessory, Surgical Apparel 1Scissors, General, Surgical 1Orthosis, Cervical 1Stretcher, Patient Restraint 1Bedding, Disposable, Medical 1Splint, Traction 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏苏械备20233031颈托Class I
CN苏苏械备20170492号医用转移车Class I
CN苏苏械备20170492医用转移车Class I
CN苏苏械备20170343号医用外固定支具Class I
EU06974580874075Class I
EU06974580877502Class I
EU06974580877014Class I
EU06974580877007Class I
UK35843Emergency StretcherClass I
UK41039Cervical CollarClass I
UK45258Head ImmobilizerClass I
SAME0000004637SFDAA00017basket stretcher
SAME0000008696SFDAA00001TRACTION SPLINT WITH SAFETY BELTS

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