Medical Device Division · registration 160209Active

Cook Biotech

Name: Cook Biotech — Medical Device Division 160209
Creator: Cook Biotech Incorporated
Keywords: Cook Biotech, Cook Biotech, 160209, Mesh, Collagen, Medical Device Division

Hong KongMesh, CollagenClass IVCook Biotech Incorporated

Verified

Official record identity

MDACS listing number: 160209
Model name: Biodesign Otologic Repair Graft (ENT-OTO-0.4-0.6, ENT-OTO-0.6-0.9, ENT-OTO-2.5X2.5, ENT-OTO-5X5)
Registration date: February 12, 2026
Expiry date: June 20, 2031
Source update date: March 16, 2026
Status: Active

Classification

Risk class: Class IV
Published category: Mesh, Collagen

Published parties

Registrant / registration holder: Cook Asia Ltd
Manufacturer: Cook Biotech Incorporated

Official description

Mesh, Collagen

Additional source fields

AMD nomenclature code: 24190
Local responsible person phone: 34721688
Published manufacturer address: 1425 Innovation Place, West Lafayette IN 47906, USA
Revision number: c

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.