HORIBA India Pvt. Ltd. has completed the Surveillance – I audit and has received a favourable recommendation for the continuation of their CE Mark Certification.
The scope of the certification includes the 1 . ABX Minoclair 100 ml 2 . ABX Minoclair 0.5L 3 . ABX Difftrol Low (1 x 3 ml) 4 . ABX Difftrol Normal (1 x 3 ml) 5 . ABX Difftrol High (1 x 3 ml) 6 . ABX Minotrol 16 Low (1 x 2.5 ml) 7 . ABX Minotrol 16 Normal (1 x 2.5 ml) 8 . ABX Minotrol 16 High (1 x 2.5 ml) 9 . ABX Minocal (1 x 2.0 ml) 10 . Yumizen CR Albumin (2x50ml) 11 . Yumizen CR Alkaline Phosphate 2x20ml, 100 ml 12 . Yumizen CR α-Amylase 1×5 ml 13 . Yumizen CR Creatinine 2×100 ml, 400 ml 14 . Yumizen CR Bilirubin Direct 2x50ml, 200 ml 15 . Yumizen CR Bilirubin Total 2x50ml, 200 ml 16 . Yumizen CR Cholesterol 2x50ml, 200 ml 17 . Yumizen CR CK NAC 2×20 ml 18 . Yumizen CR CK – MB 2 x20ml 19 . Yumizen CR gamma – GT 2x20ml 20 . Yumizen CR GOT (ASAT) 2x20ml, 200 ml 21 . Yumizen CR GPT (ALAT) 2x20ml, 200 ml 22 . Yumizen CR HbA1c 40 ml, 60 ml 23 . Yumizen CR HDL Cholesterol 40ml 24 . Yumizen CR Iron 2x20ml, 1x30ml 25 . Yumizen CR Magnesium 2x20ml 26 Yumizen CR Triglyceride 2x50ml, 200ml 27 . Yumizen CR Urea/BUN (UV) 2x50ml, 200ml 28 . Yumizen CR Uric Acid 2x50ml, 200ml 29 . Yumizen CR Glucose 5x100ml, 1000ml 30 . Yumizen CR LDL Cholesterol 2x20ml 31 . Yumizen CR Calcium 2x50ml 32 . Yumizen CR Protein – Total 2x50ml 33 . Yumizen CR Protein – Urine 2x50ml 34 . Yumizen CR C-Reactive Protein 1x20ml, 50ml 35 . Yumizen CR Rheumatoid Factors (RF) 1x20ml, 50ml 36 . Yumizen CR Anti-Streptolysin-O (ASO) 1x20ml 37 . Yumizen CR UIBC 1x30ml, 1x50ml 38 . Yumizen CR Microalbumin 2x20ml 39 . Yumizen CR Wash Solution 4x100ml 40 . Yumizen CS LDH 22.8 ml , 50 ml 41 . Yumizen CS HbA1c 60ml 42 . Yumizen CS Ferritin 60 ml 43 . Yumizen CS D-Dimer 40 ml 44 . Yumizen CS CRP CAL 1x1ml 45 . Yumizen CS RF CAL 1x3ml 46 . Yumizen CS HDL/LDL CAL 1×1 ml 47 . Yumizen CS D-Dimer CAL 1×1 ml 48 . Yumizen CS D-Di Control L & H 2x1ml 49 . Yumizen CS Ferritin CAL 5×0.5ml 50 . Yumizen CS HbA1C CAL 5×0.5ml 51 . Yumizen E-100 Fluid Pack (1 x 1 EA) 52 . Yumizen E-100 Electrode Conditioning Solution (100 ml) 53 . Yumizen E-100 ISE Cleaning Solution (100 ml) 54 . Yumizen E-100 Deproteinizer Solution (100 ml) 55 . Yumizen E-100 Urine Diluent (100 ml) 56 . Yumizen E-100 Mission Control Level 1-2-3 (30 x 1.8 ml) 57 . Yumizen E-100 Na+ Electrode (1 x1 EA) 58 . Yumizen E-100 K+ Electrode (1 x1 EA) 59 . Yumizen E-100 Ca++ Electrode (1 x1 EA) 60 . Yumizen E-100 Cl – Electrode (1 x1 EA) 61 . Yumizen E-100 Li + Electrode (1 x1 EA) 62 . Yumizen E-100 Reference Electrode (1 x1 EA) 63 . Yumizen CR ENZYMATIC CREATININE 40 ml 64 . Yumizen CR GLUCOSE HEXOKINASE 200ml 65 . Yumizen CR Phosphorus 1×30 ml 66 . Yumizen CS – ADENOSINE DEAMINASE (ADA) 60 ml 67 . Yumizen CS – ANTI-STREPTOLYSIN O (ASO) 50 ml 68 . Yumizen CS – ALBUMIN 180 ml, 240 ml 69 . Yumizen CS – ALKALINE PHOSPHATASE 150 ml, 225ml 70 . Yumizen CS – BILIRUBIN DIRECT 150 ml, 165 ml 71 . Yumizen CS – BILIRUBIN TOTAL 165 ml, 229 ml 72 . Yumizen CS – CALCIUM 60 ml, 240ml 73 . Yumizen CS – CHOLESTROL 180 ml, 240 ml 74 . Yumizen CS – CREATININE (Enzymatic) 180 ml 75 . Yumizen CS – CREATININE (Jaffe) 165 ml 76 . Yumizen CS – GAMMA-GT 150 ml, 165ml 77 . Yumizen CS – GLUCOSE HK 180 ml, 240 ml 78 . Yumizen CS – GLUCOSE PAP 180ml, 120ml 79 . Yumizen CS – GOT (ASAT) 150ml, 225ml 80 . Yumizen CS – GPT (ALAT) 150ml, 225ml 81 . Yumizen CS – HDL-CHOLESTROL 120 ml, 225ml 82 . Yumizen CS – LDL-CHOLESTROL 60ml, 80 ml 83 . Yumizen CS – LIPASE 60 ml, 61 ml 84 . Yumizen CS – MAGNESIUM 60ml, 120ml 85 . Yumizen CS – PHOSPHORUS 60ml, 232 ml 86 . Yumizen CS – TOTAL PROTEIN 180ml, 240ml 87 . Yumizen CS – TRIGLYCERIDES 180ml, 240 ml 88. Yumizen CS – UREA/BUN (UV) 150ml, 225 ml 89 . Yumizen CS – URIC ACID 90ml, 160 ml 90 . Yumizen CS – CARBON DIOXIDE 40 ml, 160 ml 91 . Yumizen CS – CK-NAC 150ml, 165 ml 92. Yumizen CS – α-AMYLASE 20ml, 80 ml, 120 ml 93 . Yumizen CS – CRP 150ml 94 . Yumizen CS – IRON 110ml, 210 ml 95 . Yumizen CS – ADA CAL 1x1ml 96 . Yumizen CS – RF 50ml 97 . Pentra Glucose (GOD-POD Method) 100ml 98 . Pentra Albumin (BCG Method) 100ml 99 . Pentra Total Protein (Biuret Method) 100ml 100 . Pentra Creatinine (Modified Jaffe’s Method) 100ml 101. Yumizen CS – CK-MB 30 ml 102. Yumizen CS Microprotein 120ml 103. Yumizen CS-Direct TIBC – 192 ml, 52 ml 104. Yumizen CS Microalbumin – 90ml.
Apart from this, HORIBA INDIA PRIVATE LIMITED can also apply for ISO 9001:2015 Certification for Quality Management System (QMS) to demonstrate its compliance with the national and international quality standards. The organization can apply for Good Manufacturing Practices (GMP) Certification to show that the company is committed to maintaining consistent manufacturing practices, product quality, and compliance with regulations.
HORIBA INDIA PRIVATE LIMITED can apply for ISO/IEC 27001:2022 certification and ISO/IEC 27701:2019 certification to enhance its information security and data privacy. Moreover, the organization can also apply for ISO 41001:2018 Certification for Facility Management – Management System to adopt the best facility management practices.
What is CE Mark Certification?
The CE Mark is a certification symbol indicating that a product complies with the European Union’s health, safety, and environmental protection standards. The certification is mandatory for products sold within the European Economic Area (EEA) and applies to a wide range of goods, including electronics, machinery, medical devices, and construction products. The CE Mark signifies that the product meets EU regulatory requirements and can be freely traded within the EEA. This certification helps facilitate trade and ensures product safety and quality within the European market.
Benefits of CE Mark Certification for HORIBA INDIA PRIVATE LIMITED:-
The benefits of CE Mark certification for HORIBA INDIA PRIVATE LIMITED are as follows:
- The CE mark facilitates HORIBA INDIA PRIVATE LIMITED legal entry into the European market. Furthermore, the certification demonstrates the organization’s compliance with European norms for selling medical devices within the European Economic Area (EEA).
- The CE Mark Certification indicates HORIBA INDIA PRIVATE LIMITED products follow high-quality standards and highlight their compliance with European standards. The certification also bolsters the organization’s credibility and marketability.
Conclusion
HORIBA INDIA PRIVATE LIMITED obtained CE Mark Certification. The certification ensures the organization’s adherence to the European Union’s safety, health, and environmental standards. Moreover, it facilitates HORIBA INDIA PRIVATE LIMITED smooth entry across the European Economic Area (EEA). CE Mark Certification ensures product safety and quality while improving the organization’s marketability in the European market.
