Our company specializes in the manufacturing, exporting, and supply of a comprehensive range of medical devices including olive oil ear drops, sodium bicarbonate ear drops, normal saline nasal drops, and CE marked products such as sodium bicarbonate 500mg capsules, ferrous fumarate 500mg capsules, thiamine hydrochloride 50mg tablets, sodium chloride inhalation and irrigation solutions, white soft paraffin, and light liquid paraffin. These medical devices serve purposes such as lubrication and nasal congestion relief but do not have any direct therapeutic effects. All products are manufactured in an ISO 13485:2012 certified facility ensuring the highest quality standards through stringent quality controls. Each batch is supported by robust stability, sterility, and manufacturing data to comply with CE Mark regulations, affirming their safety, reliability, and efficacy within the scope of medical device classification. Our focus is on maintaining product integrity and regulatory compliance to meet the demands of global healthcare suppliers and providers.
Key Features
| Features | Description |
|---|---|
| Product Range | Olive oil ear drops, sodium bicarbonate ear drops, normal saline nasal drops, sodium bicarbonate capsules, ferrous fumarate capsules, thiamine hydrochloride tablets, sodium chloride inhalation and irrigation solutions, white soft paraffin, light liquid paraffin |
| Certifications | ISO 13485:2012 certified manufacturing, CE Marked products |
| Manufacturing Quality | Strict quality checks, stability data, sterility data, batch manufacturing data maintained |
| Usage | Lubrication and nasal congestion relief without therapeutic effect |
| Compliance | Conforms to CE Mark medical device standards |
| Sterility Assurance | All products undergo comprehensive sterility and quality testing |
| Packaging | Appropriate packaging maintaining product integrity throughout shipment and storage |
| Attributes | Description |
|---|---|
| Manufacturing Standard | ISO 13485:2012 certified plant |
| Regulatory Approval | CE Mark |
| Product Types | Ear drops, nasal drops, capsules, tablets, inhalation and irrigation solutions, petrolatum-based ointments |
| Active Ingredients | Olive oil, sodium bicarbonate, sodium chloride, ferrous fumarate, thiamine hydrochloride |
| Formulation Types | Liquid drops, capsules, tablets, solution, ointments |
| Intended Use | Lubricant and relief from nasal congestion; non-therapeutic medical devices |
| Quality Control | Batch-wise stability, sterility and manufacturing data |
| Storage Conditions | Standard room temperature storage recommended (specific details available per product) |
| Packaging Details | Sealed, sterile packaging ensuring safety and integrity |
*Disclaimer: The above description has been AI-generated and has not been audited or verified for accuracy. It is recommended to verify product details independently before making any purchasing decisions.
Yes, manufactured in an ISO 13485:2012 certified plant with maintained sterility data ensuring product safety.
No, these are classified as medical devices meant for lubrication or clearing purposes and do not have therapeutic effects.
Yes, detailed stability data and batch manufacturing records are maintained for all products including capsules and tablets.
Yes, normal saline nasal drops are intended to relieve nasal congestion and are formulated as medical devices without therapeutic claims.
All medical devices are CE marked and produced in an ISO 13485:2012 certified facility ensuring compliance with international standards.
Medical devices manufacturer, exporter and supplier of olive oil ear drops, Sodium bicarbonate ear drops, normal saline nasal drops, CE Mark products, sodium bicarbonate 500mg capsule, ferrous fumarate 500mg capsule and thiamine hydrochloride 50mg tablet, sodium chloride inhalation solution, sodium chloride irrigation solution, white soft paraffin, light liquid paraffin are use to deals with the lubrication and nasal congestion and medical devices do not have any therapeutic effect.
Medical devices which we offering are manufacturing in ISO 13485: 2012 certified plant. We assure all the quality checks during manufacturing of product, our team follow the quality check points while manufacturing and ensure to take all the required steps, without comprising on quality standard since it is CE Mark Medical devices so we keep all the stability data, sterility data and batch manufacturing data in our records.
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New Delhi , India
Manufacturer, Professional Services, Contractor, Distributor, Exporter, Importer, Wholesaler