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Medical Device Division · registration 100404Active

Johnson & Johnson International

Hong KongSutures, Synthetic, Absorbable, PolydioxanoneClass IVJohnson & Johnson International
Official record identity
MDACS listing number
100404
Model name
PDS Plus Antibacterial (polydioxanone) Suture (Suture Gauge Size: 0.7 - 4.0 (metric); Suture Length: 35 cm - 245 cm; Needle Length: 7.9 mm - 70 mm; Needle Wire Diameter: 0.20 mm - 1.55 mm; Triclosan Maximum Levels </= 2360 ug/m)
Registration date
July 10, 2025
Expiry date
November 10, 2030
Source update date
July 17, 2026
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: IV
Published category
Sutures, Synthetic, Absorbable, Polydioxanone
Published parties
Registrant / registration holder
Johnson & Johnson (Hong Kong) Limited
Official description

Sutures, Synthetic, Absorbable, Polydioxanone

Additional source fields
AMD nomenclature code
16584
Traditional Chinese local responsible person
強生 (香港) 有限公司
Local responsible person phone
27386080
Published manufacturer address
c/o European Logistics Centre, Leonardo Da Vincilaan 15, BE-1831 Diegem, Belgium
Revision number
f
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.