HomeChinaCytori Therapeutics LLC.

Cytori Therapeutics LLC.

China · 上海 · www.cytori.cn
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000012840

This company holds 3 NMPA certificates in China and has registrations in European Union, United States, Canada, Singapore, Australia, Israel — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
3China registrations
Class I 1Class III 2
as of 2026-09-04
EUEuropean UnionEUDAMED
6UDI-DI device records
Class I 3Class IIa 2Class IIb 1
USUnited StatesFDA openFDA
6510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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
0valid device licences
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
11active ARTG entries
Class I 2Class III 1IIa 7IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
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 Union6 raw hits, 0 excluded, 6 confirmed
United States0 registration records, 6 510(k), 0 PMA
China3 certificates (Class III 2 / II 0 / I 1), as of 2026-09-04
Manufacturer names merged into this page: CYTORI THERAPEUTICS, INC.

Regulatory identity

EU manufacturer SRN
CN-MF-000012840
EU authorised representative
MedPath GmbH
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
23
Website
www.cytori.cn
Product categories
输血、透析和体外循环器械注输、护理和防护器械

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
2020-11-23
Registered capital
CNY 10,000,000
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company (wholly owned by a natural-person-controlled corporation)
Industry classification
Technology promotion and application services
Last approval date
2026-06-09
Recognitions
Micro and small enterpriseNational High-Tech Enterprise

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

12006 · K060482
22007 · K072587
12010 · K092923
12012 · K113255
12014 · K132815

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243101970一次性使用脂肪及脂肪基质成分处理管路套件Class III
CN国械注准20233101651自体脂肪及脂肪基质成分回收设备Class III
CN沪嘉械备20240017注射器辅助推动装置Class I
EU06974842441106CELUTIONClass IIb
EU06974842440116CELUTIONClass IIa
EU06974842440109CELUTIONClass IIa
EU06974842442103CelbrushClass I
USK132815PUREGRAFT 50 SYSTEM2014-01-24
USK113255PUREGRAFT 850/PURE SYSTEM2012-03-07
USK092923CYTORI PUREGRAFT 250/PURE SYSTEM2010-01-06

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