HomeChinaSuzhou CellPro Biotechnology Co., Ltd.

Suzhou CellPro Biotechnology Co., Ltd.

China · 苏州 · www.cellprobio.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000008875Unified social credit code 91320594MA1WPTPR34

This company has registrations in European Union, United States, Brazil — 3 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
5UDI-DI device records
Class I 4IVD A 1
USUnited StatesFDA openFDA
6listed device types
Class I 6Class II 0Class III 0
plus 6 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
2registered devices
Class I 2
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
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 Union5 raw hits, 0 excluded, 5 confirmed
United States6 registration records, 0 510(k), 0 PMA
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: SUZHOU CELLPRO BIOTECHNOLOGY CO.,LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000008875
EU authorised representative
Lotus NL B.V.
Unified social credit code
91320594MA1WPTPR34
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
104
Website
www.cellprobio.com
Product categories
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
2018-06-14
Registered capital
CNY 56,000,000
Paid-in capital
CNY 56,000,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-12-24
Recognitions
National High-Tech EnterpriseTechnology-based SMEPrivate technology enterpriseSRDI 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 listed device types

Pipette, Pasteur 1Container, Specimen, Non-Sterile 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Dish, Tissue Culture 1Bottle, Roller, Tissue Culture 1Flask, Tissue Culture 1

Registration details (sample)

MarketIdentifierNameClass / date
EU26974573530043Sampling CollectorClass I
EU26974573530029Sampling CollectorClass I
EU16974573530046Sampling CollectorClass I
EU16974573530022Sampling CollectorClass I
BR81606090045Kit para coleta PCR Covid-19Class I
BR80159280001FAMILIA FLOCKED SWAB DE NYLONClass I

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