REGENXGEN BIOSOLUTIONS PRIVATE LIMITED
India IN-MF-000026565 Last updated 21 Oct 2026
- Devices
- 44
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
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Authorised representatives
- Obelis s.a. BE
About
Discover the benefits of silicone gel sheets for effective scar management. Clinically proven to reduce redness, flatten scars, and improve skin texture after surgery or injury. Shop now for advanced healing solutions!
What REGENXGEN BIOSOLUTIONS PRIVATE LIMITED makes
The company manufactures silicone gel sheets designed for scar management, intended to reduce scar redness, flatten raised scars, and improve skin texture following surgical procedures or injuries.
These products fall under Class I medical devices and are listed in the EU’s eudamed registry. The company is based in India.
Frequently asked questions
What types of medical devices does RegenXgen Biosolutions Private Limited manufacture?
RegenXgen Biosolutions Private Limited specializes in silicone gel sheets. These devices are specifically designed for scar management, helping to reduce scar redness, flatten raised scars, and improve skin texture after surgical procedures or injuries. The focus is on aiding the healing process for patients recovering from trauma or surgery.
Where is RegenXgen Biosolutions Private Limited based?
The company is headquartered in India. This location is relevant for understanding regulatory compliance, manufacturing standards, and potential distribution networks, particularly in regional markets.
Which regulatory registries list the devices manufactured by RegenXgen Biosolutions Private Limited?
The devices produced by RegenXgen Biosolutions Private Limited are listed in the eudamed registry, which is the European database for medical devices. Listing in eudamed is required for manufacturers whose devices are placed on the EU market, ensuring transparency and traceability.
How are the devices manufactured by RegenXgen Biosolutions Private Limited classified?
The company’s silicone gel sheets for scar management fall under Class I medical device classification. This classification is typically assigned to devices posing minimal risk to patients, such as those used for external support or non-invasive treatments. Classification determines regulatory requirements, with Class I devices generally subject to fewer stringent controls compared to higher-risk categories.
Information
- Country
- India
- Address
- PLOT NO. 60, 1st FLOOR, , CHENNAI , TAMILNADU, India
- Website
- www.regenxgen.com
- [email protected]
- Phone
- +91 9884974340
- PRRC contact
- VANITA HARI KISHORE
- EUDAMED SRN
- IN-MF-000026565