WELDON BIOTECH (INDIA) PRIVATE LIMITED has completed the Surveillance audit and received a favourable recommendation for the continuation of their CE Mark Compliance.
The scope of the management system includes Diluent, Rinse, Detergent, Lyse (Lytic Reagent), EZ Cleaner, Probe Cleaner, Proclean, Diluid, Detectoterge, T3 ELISA, T4 ELISA, TSH ELISA, FT3 ELISA , FT4 ELISA, FSH ELISA, LH ELISA, PRL ELISA, t-PSA ELISA, f-PSA ELISA, CA-125 ELISA, CA-19.9 ELISA, CA-15.3 ELISA , CEA ELISA, 25-hydroxy (25-OH) (Vitamin D) ELISA, Vitamin B-12 ELISA, Folate (Vitamin B-9) ELISA, Anti – Mullerian Hormone ELISA, Anti-Cyclic Citrullinated Peptide (Anti CCP) ELISA, IgE ELISA, hCG ELISA, AFP (Alfa-Fetoprotein) ELISA, TTG (Tissue Trans Glutaminase) ELISA, Adenosine Deaminase (ADA), ADA Calibrator, ADA Low Control, ADA High Control, LDL Cholesterol, HDL Cholesterol, HDL/LDL Cholesterol Calibrator, Total Cholesterol, Homocysteine, ACE (Angiotensin Converting Enzyme), ACE Calibrator, ACE Low Control, ACE High Control, HbA1c, D-Dimer, Lp(a) (Lipoprotein), Glucose (GOD/POD Method), Creatinine, Bilirubin, Glucose-6-Phosphate Dehydrogenase (G-6PDH), Triglycerides, Uric Acid (Uricase-Paptrinder’s Method), Sodium, Potassium (Tetra Phenyl Borate Method), Calcium (ARSENAZO III Method), Ammonia UV, Amylase, Albumin, Total Protein, Phosphorus (Molybdate-UV Method), SGOT (Serum Glutamic-Oxaloacetic Transaminase) (By IFCC Method), SGPT (Serum Glutamic-Pyruvic Transaminase) (By IFCC Method), Urea-UV (GLDH Method), Alkaline Phosphatase (By DEA Method), Microprotein (By Pyrogallol Red Method), Magnesium, Cholinesterase, Iron, Total Iron Binding Capacity, Creatine Kinase-Muscle/Brain (CK-MB), N-acetyl-Cystein-(NAC)-activated Creatine Kinase (CK-NAC), Heamoglobin, Malaria Rapid Card, Dengue Rapid Card, Leptospira Rapid Card Diluent Sysmex, Lyse Sysmex, Chloride, Stop Solution, Water for Diagnostic Use Wash Solution, Cleaning Solution for semi auto biochemistry analyzer (Wel-Clean), 5-Part Diluent, Diluent WelCount 3+, Lyse WelCount 3+, Probe Cleaner WelCount 3, Standard A (Electrolyte Analyzer), Standard B (Electrolyte Analyzer), Low Quality Control (Electrolyte Analyzer), Normal Quality Control (Electrolyte Analyzer), High Quality Control (Electrolyte Analyzer), Daily Cleaning Solution (Electrolyte Analyzer), Wel-Chem LDL Cholesterol Calibrator, Wel-Chem HDL Cholesterol Calibrator, Cleaning Solution for fully auto biochemistry analyzer (Wel Super Clean), Wel-Hem 5-Part Lyse-H, Wel-Hem 5-Part Lyse-D Wel-Hem 5-Part Probe Cleaner, Wel-Chem Gamma GT (GGT) Assay Kit, Wel-Chem Lactate Dehydrogenase (LDH) assay Kit, Wel-Chem Lipase Assay Kit, Wel-Chem Carbon dioxide (CO2)/Biocarbonate Assay Kit, Wel-Chem Microalbumin assay kit, Wel-Chem Acid Phosphatase (ACP) assay kit, Wel-Chem Total bile acid (TBA) assay kit, Wel-Chem Lactate assay kit, Wel-Chem Glucose Hexokinase assay kit, Wel-Chem Homocystein multi calibrator set, ASO (Turbilatex) assay kit, RF (Turbilatex) assay kit.
WELDON BIOTECH (INDIA) PRIVATE LIMITED can also apply for Good Manufacturing Practices (GMP) Compliance to show its commitment to maintaining consistent product quality and compliance with regulations. The organization can apply for ISO 9001:2015 Certification for Quality Management System (QMS).
What is CE Mark Certification?
The CE Mark is a certification symbol that proves a product meets the European Union’s stringent safety, health, and environmental protection standards. Mandatory for goods sold within the European Economic Area (EEA), it covers a wide range of products from electronics and machinery to medical devices and construction materials. More than just a label, the CE Mark signals full compliance with EU legislation and grants access to seamless trade across the EEA. It acts as a passport for market entry and a safety, quality, and regulatory alignment within the European marketplace.
Benefits of CE Mark Compliance for WELDON BIOTECH (INDIA) PRIVATE LIMITED
The benefits of CE Mark compliance for WELDON BIOTECH (INDIA) PRIVATE LIMITED are as follows:
- The CE mark facilitates WELDON BIOTECH (INDIA) PRIVATE LIMITED’s legal entry into the European market. The standard demonstrates the organization’s compliance with European guidelines for selling medical devices within the European Economic Area (EEA).
- The CE Mark compliance indicates that WELDON BIOTECH (INDIA) PRIVATE LIMITED’s products follow high-quality standards and demonstrate its adherence to European standards.
Conclusion
WELDON BIOTECH (INDIA) PRIVATE LIMITED obtained CE Mark Compliance. It ensures the organization’s compliance with the European Union’s safety, health, and environmental standards. CE marking also facilitates WELDON BIOTECH (INDIA) PRIVATE LIMITED’s smooth entry across the European Economic Area (EEA).
 PRIVATE LIMITED has completed the Surveillance audit and received a favourable recommendation for the continuation of their CE Mark Compliance.){kind=link}