Zhejiang Greylynx Biotech Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000032462
- Devices
- 165
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
Catalogue
Strep B Rapid Test Ref GISTB-702
Strep A Rapid Test Ref GISTA-702H(25T/kit)
HSV 1/2 IgG Rapid Test Ref GIHSV1/2G-422
Legionella Pneumophila Rapid Test Ref GILeg-502
Legionella Rapid Test Ref GILeg-502
C. difficile Toxin A/B Rapid Test Ref GICD-622
Adenovirus/RSV/Influenza A+B Combo Rapid Test Ref GIARF-742
C. difficile Toxin A/B+GDH Rapid Test Ref GICD-632
Dengue IgG/IgM and NS1 Combo Test Ref GIDEN-432
Malaria P.f./P.v. Rapid Test Ref GIMALfv-922
Strep A Rapid Test Ref GISTA-702H(5T/kit)
Dengue IgG/IgM and NS1 Combo Rapid Test Ref GIDEN-432
Multiple Drugs of Abuse/Toxicology Rapid Test Ref GDMEP-A101
Malaria P.f./P.v./Pan Rapid Test Ref GIMP-932
SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test Ref GISFR-742
SARS-CoV-2 IgM/IgG Rapid Test Ref GISARSgm-722
SARS-CoV-2/Influenza A+B/RSV/Adenovirus Ag Combo Rapid Test Ref GISFRA-702H
Strep A Rapid Test Ref GISTA-702H(2T/kit)
Strep A Rapid Test Ref GISTA-702H(1T/kit)
Giardia Lamblia Rapid Test Ref GIGIL-602
Astrovirus Rapid Test Ref GIASV-602
MMescaline (MES) Rapid Test Ref GDMES-B102
Calprotectin/Lactoferrin Combo Rapid Test Ref GTCL-622
Methamphetamine (MET) Rapid Test Ref GDMET-A102
Zika NS1 Rapid Test Ref GIZNS1-402
Lysergic Acid Diethylamide (LSD) Rapid Test Ref GDLSD-A102
Myoglobin Rapid Test Ref GCMYO-402
Benzodiazepines (BZO) Rapid Test Ref GDBZO-A102
Strep A Rapid Test Ref GIST-702
Clonazepam (CLO) Rapid Test Ref GDCLO-A102
Oxycodone (OXY) Rapid Test Ref GDOXY-A102
Synthetic Marijuana (K2) Rapid Test Ref GDSPC-A102
Drugs of Abuse Rapid Test Panel Ref GDMDPV-A104
hCG Pregnancy Rapid Test Midstream Ref GHHCG-B103A
Ferritin Semi-Quantitative Rapid Test Ref GTFT-602
Norfentanyl (FEN) Rapid Test Ref VDNFYL-C102
Rota-Adenovirus Test Ref GIRA-622
Tuberculosis IgG/IgM Rapid Test Ref GITBb-402
Malaria P.f. Rapid Test Ref GIMALf-902
Multiplex Respiratory Antigen Combo Rapid Test Ref GINRAA-642 NoV/RV/ADV/Astro
Campylobacter Rapid Test Ref GICB-A602
Campylobacter Test Ref GICB-A602
Micro-Albumin Semi-Quantitative Rapid Test Ref GTMAUS-602
Marijuana (THC) Rapid Test Ref GDTHC-A102
Norovirus GI/GII Test Ref GINOV-622
S.pneumoniae Rapid Test Ref GISPNE-502
Tricyclic Antidepressants (TCA) Rapid Test Ref GDTCA-A102
HAV IgM Rapid Test Ref GIHAVm-402
FOB Rapid Test Ref GTFOB-A602
Giardia Rapid Test Ref GIGI-602
Showing 1-50 of 165
Company details
- EUDAMED SRN
- CN-MF-000032462
- EUDAMED status
- Active
- EUDAMED registered name
- Zhejiang Greylynx Biotech Co., Ltd.
- Registered address
- Building 3, No. 17 Wuzhou Road, Donghu Street, Linping District, 311199, Hangzhou, Zhejiang, China
- [email protected]
- PRRC contact
- CHENGLIN ZHU
EUDAMED certificates
2 certificates2 valid, 0 expiredIVDR 2next expiry 12 Mar 2030
TÜV Rheinland LGA Products GmbH 0197 2 certificates
- HX 2566030-1 Issued
Quality management system EU IVDR
- Issued
- 13 Mar 2025
- Expires
- 12 Mar 2030
- IX 2566030-1 Issued
Technical documentation EU IVDR
- Issued
- 13 Mar 2025
- Expires
- 12 Mar 2030
Frequently asked questions
How many devices does Zhejiang Greylynx Biotech Co., Ltd. have in the registry?
The registry currently lists 165 devices for Zhejiang Greylynx Biotech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zhejiang Greylynx Biotech Co., Ltd.'s devices?
Among its 50 most recently registered devices, Zhejiang Greylynx Biotech Co., Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do Zhejiang Greylynx Biotech Co., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Zhejiang Greylynx Biotech Co., Ltd.'s devices are IVDR Class C and IVD general. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Zhejiang Greylynx Biotech Co., Ltd.?
EUDAMED lists 2 certificates for Zhejiang Greylynx Biotech Co., Ltd. (quality management system; technical documentation) under IVDR. 2 are recorded with the status issued. The most recent was issued on 2025-03-13.
What are the newest devices from Zhejiang Greylynx Biotech Co., Ltd. in the registry?
The most recently registered devices listed for Zhejiang Greylynx Biotech Co., Ltd. include Strep B Rapid Test, Strep A Rapid Test, HSV 1/2 IgG Rapid Test and Legionella Pneumophila Rapid Test.