Medical Device Division · registration 110057CancelledCook Biotech
Hong KongGraftsClass IVCook Biotech Incorporated
Official record identity
- MDACS listing number
- 110057
- Model name
- Biodesign Hernia Graft (C-SLH-8H-10x10, C-SLH-8H-13x15, C-SLH-8H-13x22, C-SLH-8H-20x20, C-SLH-8H-20x30)
- Registration date
- May 06, 2021
- 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 IN 47906, USA
- Published remarks
- Delisted.
- Revision number
- b
- 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.