Pure Global AI
Medical Device Division · registration 110430Active

Ethicon

Hong KongMesh, PolymericClass IIIEthicon, Inc.
Official record identity
MDACS listing number
110430
Model name
PROLENE Hernia System (PHSE1, PHSE, PHSE6, PHSL1, PHSL, PHSL6, PHSM1, PHSM, PHSM6)
Registration date
March 11, 2026
Expiry date
November 21, 2031
Source update date
July 17, 2026
Status
Active
Official value: Valid
Classification
Risk class
Class III
Official value: III
Published category
Mesh, Polymeric
Published parties
Registrant / registration holder
Johnson & Johnson (Hong Kong) Limited
Manufacturer
Ethicon, Inc.
Official description

Mesh, Polymeric

Additional source fields
AMD nomenclature code
12510
Traditional Chinese local responsible person
強生 (香港) 有限公司
Local responsible person phone
27386080
Published manufacturer address
1000 route 202, Raritan, New Jersey, 08869, USA
Revision number
d
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.