HomeChinaWuxi NEST Biotechnology Co., Ltd.

Wuxi NEST Biotechnology Co., Ltd.

China · 无锡 · www.cell-nest.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000002299Unified social credit code 91320213685882797G

This company holds 12 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Australia, Russia — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
12China registrations
Class I 7Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
17UDI-DI device records
Class IIb 16IVD A 1
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 3 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class I 2IVD general 2
BRBrazilANVISA
10registered devices
Class I 2Class 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
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 1 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 Union63 raw hits, 46 excluded, 17 confirmed
United States3 registration records, 4 510(k), 0 PMA
China12 certificates (Class III 0 / II 5 / I 7), as of 2026-09-04
United Kingdom4 confirmed, 5 excluded
Brazil10 confirmed, 0 excluded
Manufacturer names merged into this page: WUXI NEST BIOTECHNOLOGY CO., LTD · WUXI NEST BIOTECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000002299
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91320213685882797G
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
481
Annual revenue
RMB 100–500M
Website
www.cell-nest.com
Product categories
体外诊断注输、护理和防护器械临床检验器械及试剂

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
2009-03-06
Registered capital
CNY 360,000,000
Paid-in capital
CNY 360,000,000
Legal form
Joint-stock limited company (foreign-invested)
Industry classification
Rubber and plastic products
Last approval date
2026-07-13
Recognitions
National High-Tech EnterpriseNational SRDI "Little Giant"Gazelle enterpriseInnovative SME

Business registration data from Tianyancha, as of 2026-09-03. 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 · K210440
12022 · K211256
22024 · K240961

FDA listed device types

Nasal Spray, Ent Delivery 1Syringe, Piston 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20262140629内旋式笔式注射器Class II
CN苏械注准20252141772笔式注射器Class II
CN苏械注准20242140449笔式注射器Class II
CN苏械注准20212221578一次性使用无菌采样拭子Class II
EU26973122863595IVD A
EU06941854802706Pen InjectorClass IIb
EU06941854803239Pen InjectorClass IIb
EU06941854803222Pen InjectorClass IIb
UK10226Disposable intranasal atomization deviceClass I
UK63232Disposable samplerIVD general
UK33722Specimen collection swabClass I
USK240961Disposable Pen Injector Assembly2024-08-15
USK240774Pen Injector2024-06-18
USK211256Disposable Sampler Viral Transport Media2022-05-20
BR80102519343Caneta InjetoraClass II
BR82533959045Acufocus - Caneta descartável para aplicação de medicamentosClass II
BR82539449001CANETA INJETORA DE INSULINA E PEPTIDEOSClass II

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