F NO :

Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
Ministry of Health and Family welfare
(Medical Device and Diagnostic Division)

FREE SALE CERTIFICATE

FSC Number : FSC/IVD/2023/000095 Dated : 08/06/2023

This is to certify that M/s. Trivitron Healthcare Pvt. Ltd. ,Trivitron Healthcare Pvt. Ltd.
situated at address A-16 ,M.I.D.C, Patalganga Industrial Area, Tehsil - Khalapur, ,
Raigad Maharashtra ,410220,7824807736, India is holding Manufacturing License no.
MFG/IVD/2023/000038 issued on 04-MAR-2023 Under this license, the said firm is
permitted to manufacture the products for their manufacture and sale in domestic market as
per Indian Law and for export as per law of importing country (ies):-

Name of the products with their product name and dimensions if any mentioned below :

S.NO Medical Device Details

1. Generic Name :Semi Automatic Biochemistry Analyzer
1
2. Brand Name :Labmate NXT
3. Notified Category :Other than above substancesIVD Analyzer
4. Class of Medical Device :Class A
5. Shelf life :5 Years
6. Sterile/Non-Sterile:Non-Sterilized
7. Intended Use :An analyzer intended to be used for the qualitative
determination of one or more multiple clinical chemistry analytes in a
Serum/Plasma/whole blood.
8. Material of Construction: ABS Body PCB’s Cables and connectors Various
Steel and Al parts.
9. Dimension: 345 mm x 280 mm x150 mm
10. Model/Catalogue No./Name :NIL
1. Generic Name :Semi Automatic Biochemistry Analyzer
2
2. Brand Name :Labmate Plus
3. Notified Category :Other than above substancesIVD Analyzer
4. Class of Medical Device :Class A
5. Shelf life :5 Years
6. Sterile/Non-Sterile:Non-Sterilized
7. Intended Use :An analyzer intended to be used for the qualitative
determination of one or more multiple clinical chemistry analytes and
determination of coagulation type in a Serum/Plasma/whole blood.
8. Material of Construction: ABS Body PCB’s Cables and connectors Various
Steel and Al parts.
9. Dimension: 345mm x 311 mm x 150 mm
10. Model/Catalogue No./Name :NIL
 1. Generic Name :Fully Automated Biochemistry Analyzer
3
2. Brand Name :Nanolab 200
3. Notified Category :Other than above substancesIVD Analyzer
4. Class of Medical Device :Class A
5. Shelf life :5 Years
6. Sterile/Non-Sterile:Non-Sterilized
7. Intended Use :An analyzer intended to be used for the qualitative
determination of one or more multiple clinical chemistry analytes in a
Serum/Plasma/whole blood.
8. Material of Construction: ABS Body PCB’s Cables and connectors Various
Steel and Al parts
9. Dimension: 850 mm x 650mm x 400 mm
10. Model/Catalogue No./Name :NIL
1. Generic Name :Automated Hematology Analyzer
4
2. Brand Name :Cellenium 21
3. Notified Category :Other than above substancesIVD Analyzer
4. Class of Medical Device :Class A
5. Shelf life :NIL
6. Sterile/Non-Sterile:Non-Sterilized
7. Intended Use :The hematology analyzer is appropriate to the qualitative and
quantitative analysis of the visible components in human being blood.
8. Material of Construction: NA
9. Dimension: NA
10. Model/Catalogue No./Name :NIL
1. Generic Name :5-Part-Diff Auto Hematology Analyzer
5
2. Brand Name :Cellenium 5D Retic
3. Notified Category :Other than above substancesIVD Analyzer
4. Class of Medical Device :Class A
5. Shelf life :NIL
6. Sterile/Non-Sterile:Non-Sterilized
7. Intended Use :5-Part-Diff Auto Hematology Analyzer is for blood cell count,
WBC five-part differential and hemoglobin concentration measurement in clinical
laboratory.
8. Material of Construction: NA
9. Dimension: NA
10. Model/Catalogue No./Name :NIL

DUSHYANT Digitally signed by DUSHYANT

MOTIRAM BHAMRAY
MOTIRAM Date: 2023.06.08 16:22:32
BHAMRAY +05'30'

Competent Authority