Chanda Owens

FDA Filings

This page includes the latest FDA filings for Chanda Owens. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011545635
FEI Number3011545635
NameChanda Owens
Owner & OperatorASP International GmbH Zweigniederlassung Zug
Contact AddressGubelstrasse 34
Zug CH-ZG Zug 6300 CH
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address33 Technology Drive
Irvine, CA 92618 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3004418109
FEI Number3002806695
NameChanda Owens
Owner & OperatorCILAG AG
Contact AddressCilag AG Hochstrasse 201
SCHAFFHAUSEN CH-SH Schaffhausen 8200 CH
Official Correspondent
  • Dirk - Overroedder
  • 41-52-6309285-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address33 TECHNOLOGY DR
Irvine, CA 92618 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Chanda Owens [ASP International GmbH Zweigniederlassung Zug]
GA Indicator Cidex Solution Test Strips2014-12-02
Chanda Owens [ASP International GmbH Zweigniederlassung Zug]
Cidex OPA Indicator2014-12-02
Chanda Owens [ASP International GmbH Zweigniederlassung Zug]
CIDEX? Solution Test Strips2014-12-02
Chanda Owens [ASP International GmbH Zweigniederlassung Zug]
Cidex Activated Dialdehyde Solution2014-12-02
Chanda Owens [ASP International GmbH Zweigniederlassung Zug]
CIDEX? Activated Glutaraldehyde Solution2014-12-02
Chanda Owens [ASP International GmbH Zweigniederlassung Zug]
Cidex OPA Concentrate2014-12-02
Chanda Owens [ASP International GmbH Zweigniederlassung Zug]
CIDEX? OPA ortho-Phthalaldehyde High Level Disinfectant Solution2014-12-02
Chanda Owens [ASP International GmbH Zweigniederlassung Zug]
Cidex OPA2014-12-02
Chanda Owens [ASP International GmbH Zweigniederlassung Zug]
CIDEX? OPA Solution2014-12-02
Chanda Owens [CILAG AG]
STERRAD 100NX Cassette DUO Cycle2013-12-09
Chanda Owens [CILAG AG]
STERRAD 100NX Sterilizer with EXPRESS Cycle2013-01-15
Chanda Owens [CILAG AG]
STERRAD 50 Sterilisation System and STERRAD 100S Sterilisation System2013-01-15
Chanda Owens [CILAG AG]
STERRAD 100S Cassettes2008-08-07
Chanda Owens [CILAG AG]
STERRAD 50 Cassettes2008-08-07
Chanda Owens [CILAG AG]
STERRAD 100NX Cassettes2008-08-07
Chanda Owens [CILAG AG]
STERRAD NX Cassettes2008-08-07
Chanda Owens [CILAG AG]
STERRAD 200 Cassettes2008-08-07
Chanda Owens [CILAG AG]
STERRAD 200 Cassettes2008-08-07

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