HomeChinaSHAOXING UNDIS MEDICAL TECHNOLOGY CO.,LTD.

SHAOXING UNDIS MEDICAL TECHNOLOGY CO.,LTD.

China · 绍兴 · www.undis.cn
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000002187Unified social credit code 91330600055501283D

This company holds 12 NMPA certificates in China and has registrations in European Union, United States, Brazil, Australia, Hong Kong, Israel — 6 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
12China registrations
Class I 3Class II 9
as of 2026-09-01
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class IIa 300
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 17Class II 0Class III 0
plus 17 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
9registered devices
Class I 1Class II 8
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 5
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
1registrations
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 Union648 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States17 registration records, 0 510(k), 0 PMA
China12 certificates (Class III 0 / II 9 / I 3), as of 2026-09-01
Brazil9 confirmed, 0 excluded
Manufacturer names merged into this page: SHAOXING UNDIS MEDICAL TECHNOLOGY COMPANY LIMITED · SHAOXING UNDIS MEDICAL TECHNOLOGY CO LTD. · Shaoxing Undis Medical Technology CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000002187
EU authorised representative
Lotus NL B.V.
Unified social credit code
91330600055501283D
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
106
Website
www.undis.cn
Product categories
呼吸、麻醉和急救器械

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
2012-10-08
Registered capital
CNY 12,500,000
Paid-in capital
CNY 9,500,000
Legal form
Limited liability company
Industry classification
Other manufacturing
Last approval date
2024-12-02
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEInnovative 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 17
Mouthpiece, Breathing 1Accessory, Surgical Apparel 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Non-Surgical Gown 1Set, Tubing And Support, Ventilator (W Harness) 1Cannula, Nasal, Oxygen 1Mask, Oxygen 1Bag, Reservoir 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20212080354一次性使用密闭式吸痰管Class II · 2026-01-08
CN浙械注准20162080593一次性使用呼吸过滤器Class II · 2025-10-16
CN浙绍械备20250095一次性吸引管Class I · 2025-08-26
CN浙械注准20252081569人工复苏器Class II · 2025-08-05
EU26970531332476Closed suction systemsClass IIa
EU16970531332479Closed suction systemsClass IIa
EU06970531332472Closed suction systemsClass IIa
EU26970531332469Closed suction systemsClass IIa
BR81760459006Micronebulizador NetMask DescartávelClass II
BR81760450012Máscara Almofadada descartável NetMaskClass I
BR10150479092Sonda de Aspiração Sistema Fechado Undis MedicalClass II

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