Cell Culture Products:
The OriGen Permalife cell culture bag is
Business Purpose: Working with Customers to
innovate medical devices that exceed their
expectations
Corporate Milestones
• 1991 - Origen receives its first patent, for a
mechanical heart valve
• 1994 - received FDA 510k approval for the
Permalife cell culture bag
• 2001 - received FDA 510k approval for our
ECMO catheters
• 2001 - received ISO CE-mark approval for all
existing products
• 2003 - received FDA/ EU approval for CryoStore
cryopreservation bags
• 2008 - Received CE-mark approval for DMSO
and Perfluorocarbon lavage solutions
Core Competencies
• Design: 50 Years combined experience in
medical device design and manufacture
• Manufacturing: worldwide GMP approvals
• Regulatory: Worldwide medical device
approvals
• Quality: Demonstrated reliability and Quality in
Design
• Customer-Focus: Commitment to delivering what
our customers want
ECMO products:
OriGen provides a range of unique disposables for
ECMO, an advanced respiratory support therapy
system. Our products include catheters, an
introducer kit, a filtration tubing set, bladder box
pump controller and Perflurocarbon lung lavage
solutions.
7000 Burleson Rd. Bldg D, Austin, TX, USA 78744 • www.origen.com • +1 512 474 7278
unsurpassed for cell culture applications. A
breathable closed system, it is much less likely to
become contaminated than dish or flask methods.
These are widely used in stem cell and cancer
research.
Cryopreservation Products:
Our EVA and proprietary EVO products are ideal
for long-term cryopreservation. Suitable for
freezing at any temperature, our CryoStore,
CryoBag and OverWrap are used in hospitals and
research labs around the world. We also provide
a range of accessory sets for transfer and
engraftment.
Commitment to Quality
Quality is designed into each product, and OriGen
is audited regularly by FDA, ISO-certification
organizations and customers. We maintain
worldwide certification to GMPs, ISO 13485 and
the European 92/43 Medical Device Directive.
Why Choose OriGen?
Experience, Dedication and Quality: We listen to
our customers and work with them to develop
products to meet their needs. You can be sure that
the same attention to detail has gone into every
product with the OriGen label.
Manufacturing Facilities
The Austin, Texas office is the company
headquarters. All design, manufacturing,
distribution, sales and marketing efforts are
handled through the Austin office.
Our Helsingborg, Sweden logistics center
manufactures a few custom products for use in
Europe, handles distribution in the EU, Middle
East, Africa and Eastern Europe, and monitors
regulatory changes in the EU.