Regulatory & Quality
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
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 |
Phone: |
+1 (800) 220-9082 |
MANUFACTURER
Legal Manufacturer |
REGEN LAB SA |
Address |
En Budron B2 |
Extension (storage area) |
En Budron C5 |
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)