Accreditations

In order to assure the safety of our tissue grafts, Tutogen Medical, Inc. meets or exceeds all AATB, state, and federal guidelines.

Regulatory Letter to Customers


US Food & Drug Administration Registrations

US HCT/P FDA Regulations
US Device FDA Regulations
Germany HCT/P FDA registration
Germany Device FDA registration


Canada CTO Registrations

US CTO Registration
Germany CTO Registration


American Association of Tissue Banks

AATB Accredited
AATB Accreditation Certificate


ISO

Certified to ISO 9001:2000 and ISO 13485:2003 by LGA InterCert
US 9001 Certificate
US 13485 Certificate
Germany 9001 Certificate
Germany 13485 Certificate

States

California: Tissue Bank ID Number: CNC 80456
Delaware: Registered
Florida: Certificate #498, License #21
Illinois: Registration #2206
Maryland: Tissue Bank Permit: TB 1333
New York: Tissue Bank ID No.: CP086TP069


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