Medical Device Division · registration 110349CancelledCook Biotech
Hong KongGraftsClass IVCook Biotech Incorporated
Official record identity
- MDACS listing number
- 110349
- Model name
- Biodesign 1-Layer Tissue Graft (SLH-1S-7X10), Biodesign 4-Layer Tissue Graft (C-SLH-4S-1X10, C-SLH-4S-2X3, C-SLH-4S-4X7, C-SLH-4S-7X10, C-SLH-4S-7X20, J-SLH-4S-4X7, J-SLH-4S-7X10, J-SLH-4S-7X20)
- Registration date
- December 08, 2023
- Source update date
- August 20, 2025
- Status
- Cancelled
Official value: Delisted
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Cook Asia Ltd
- Manufacturer
- Cook Biotech Incorporated
Official description
Grafts
Additional source fields
- AMD nomenclature code
- 11908
- Local responsible person phone
- 34721688
- Published manufacturer address
- 1425 Innovation Place, West Lafayette, Indiana 47906, USA
- Published remarks
- Delisted.
- Revision number
- c
- Delist date
- 2025-08-20
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.