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Manufacturer (both Legal & Contract)

& U.S. Authorized Agent




Manufacturers make by chemical, physical, biological, or other procedures, any article that meets the definition of “device” in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.  Contract Manufacturers produce a finished device to another establishment’s specifications. U.S. Authorized Agents of foreign Manufacturers are responsible for assisting in communication with, response to question concerning, an assistance in scheduling of inspections of the foreign establishment they are associated with.

Manufacturer (both Legal & Contract)

& U.S. Authorized Agent:

RegenLab USA, LLC

Address:

140A 58th St, Brooklyn Army Terminal

Brooklyn, NY 11220

Contact Information:

Chief Executive Officer:  Dr. Giuseppe Calloni
Regulatory Compliance:  Dr. Daphne Van Diermen
Complaints:  customercare@regenlabusa.com

Phone:

+1 (800) 220-9082



MANUFACTURER

Legal Manufacturer

REGEN LAB SA

Address

En Budron B2
1052 Le Mont-sur-Lausanne
Switzerland (CH)

Extension (storage area)

En Budron C5
1052 Le Mont-sur-Lausanne
Switzerland (CH)

Phone

+41 (0) 21 864 01 11

Fax

+41 (0) 21 864 01 10

Contact Regenlab® USA

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Our Regional offices are
located in

  • New York (USA)
  • Montréal (Canada)
  • Venice (Italy)
  • Munich (Germany)
  • Paris (France)
  • Dubai (U.A.E.)
  • Beijing (China)
  • and Istanbul (Turkey)