Suzhou Sym-Bio Lifescience Co., Ltd.

China CN-MF-000012847 Last updated 8 Jun 2026

Devices: 29
Registries: EUDAMED
FDA recalls: 0

Catalogue29

Automated Chemiluminescence Analyzer Ref SY36

Class A EUDAMED Active
SuperFlex uE3 Kit Ref SY488QG

Class C EUDAMED Active
Nucleic Acid Extraction Kit Ref SY609

Class A EUDAMED Active
Automated Workstation Ref SY61-01

Class A EUDAMED Active
SuperFlex AMH Kit Ref SY434QG

Class B EUDAMED Active
SuperFlex Free hCGβ Kit Ref SY460QG

Class C EUDAMED Active
SuperFlex PAPP-A Kit Ref SY456QG

Class C EUDAMED Active
SuperFlex AFP Kit Ref SY490QG

Class C EUDAMED Active
Automated Workstation Ref SY61

Class A EUDAMED Active
SuperFlex sFlt-1 Kit Ref SY430QG

Class C EUDAMED Active
SuperFlex Inhibin A Kit Ref SY489QG

Class C EUDAMED Active
SuperFlex PlGF Kit Ref SY428QG

Class C EUDAMED Active
SuperFlex Myoglobin Kit Ref SDX-57019

Class C EUDAMED Active
SuperFlex PCT Control Ref SDX-57004

IVD General EUDAMED Active
SuperFlex N-Terminal Pro-Brain Natriuretic Peptide Kit Ref SDX-57024

Class C EUDAMED Active
SuperFlex Procalcitonin Kit Ref SDX-57003/SDX-57032

Class C EUDAMED Active
SuperFlex High Sensitivity Cardiac Troponin I Kit Ref SDX-57015

Class C EUDAMED Active
SuperFlex IL-6 Control Ref SDX-57029

IVD General EUDAMED Active
Pre-NAT II (SY61-EI) Ref SY61-EI

Class A EUDAMED Active
SuperFlex CK-MB Control Ref SDX-57012

IVD General EUDAMED Active
SuperFlex D-Dimer Control Ref SDX-57037

IVD General EUDAMED Active
SuperFlex cTnI Control Ref SDX-57016

IVD General EUDAMED Active
SuperFlex All in One C-Reactive Protein Kit Ref SDX-57007

Class C EUDAMED Active
SuperFlex Ref SUPERFLEX-CE

Class A EUDAMED Active
SuperFlex CRP Control Ref SDX-57008

IVD General EUDAMED Active
SuperFlex Interleukin-6 Kit Ref SDX-57028

IVD General EUDAMED Active
SuperFlex MYO Control Ref SDX-57021

IVD General EUDAMED Active
SuperFlex D-Dimer Kit Ref SDX-57036

Class C EUDAMED Active
SuperFlex Creatine Kinase-MB Kit Ref SDX-57011

Class C EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

TÜV SÜD Product Service GmbH 0123 1 certificate

V13 073388 0009 Supplemented

Quality management system EU IVDR

Issued
3 Aug 2026

Expires
14 Nov 2027

Reason
Add device or group

Authorised representatives

Emergo Europe B.V. NL

Notified bodies

TÜV SÜD Product Service GmbH 0123

Information

Country: China
Address: No.115, North Tai Ping Road, Taicang Economic Development Zone, Jiangsu Province, China
Website: revvity.com
Email: [email protected]
Phone: +086 010-89194387
PRRC contact: Xi Fei
EUDAMED SRN: CN-MF-000012847

Catalogue29

Automated Chemiluminescence Analyzer Ref SY36

SuperFlex uE3 Kit Ref SY488QG

Nucleic Acid Extraction Kit Ref SY609

Automated Workstation Ref SY61-01

SuperFlex AMH Kit Ref SY434QG

SuperFlex Free hCGβ Kit Ref SY460QG

SuperFlex PAPP-A Kit Ref SY456QG

SuperFlex AFP Kit Ref SY490QG

Automated Workstation Ref SY61

SuperFlex sFlt-1 Kit Ref SY430QG

SuperFlex Inhibin A Kit Ref SY489QG

SuperFlex PlGF Kit Ref SY428QG

SuperFlex Myoglobin Kit Ref SDX-57019

SuperFlex PCT Control Ref SDX-57004

SuperFlex N-Terminal Pro-Brain Natriuretic Peptide Kit Ref SDX-57024

SuperFlex Procalcitonin Kit Ref SDX-57003/SDX-57032

SuperFlex High Sensitivity Cardiac Troponin I Kit Ref SDX-57015

SuperFlex IL-6 Control Ref SDX-57029

Pre-NAT II (SY61-EI) Ref SY61-EI

SuperFlex CK-MB Control Ref SDX-57012

SuperFlex D-Dimer Control Ref SDX-57037

SuperFlex cTnI Control Ref SDX-57016

SuperFlex All in One C-Reactive Protein Kit Ref SDX-57007

SuperFlex Ref SUPERFLEX-CE

SuperFlex CRP Control Ref SDX-57008

SuperFlex Interleukin-6 Kit Ref SDX-57028

SuperFlex MYO Control Ref SDX-57021

SuperFlex D-Dimer Kit Ref SDX-57036

SuperFlex Creatine Kinase-MB Kit Ref SDX-57011

EUDAMED certificates1

TÜV SÜD Product Service GmbH 0123 ·1 certificate

Related companies

Authorised representatives

Notified bodies

Information

TÜV SÜD Product Service GmbH 0123 1 certificate