Medical Device Division · registration 230338ActiveAssut Europe
Hong KongSutures, Synthetic, Absorbable, PoliglecaproneClass IVAssut Europe SPA
Official record identity
- MDACS listing number
- 230338
- Model name
- MONOFIL FAST - Sterile Poly(glycolide-co-ε-caprolactone) monofilament synthetic surgical suture, short term absorption (FW375Q, FV389Q, FW378Q, FV386Q, FU395Q, FV802Q, FU799Q, FS797Q, FR801Q, FU246Q, FS248Q, FV798Q, FU440Q, FS464Q, FR465Q, FU800Q, FS445Q, FR458Q, FS414Q, FR479Q, FR887Q, FS730Q, FW515Q, FV516Q, FV533Q, FU534Q, FY484Q, FX487Q, FY488Q, FX489Q, FW492Q, FX505Q, FW812Q, FV526Q, FW522Q, FV523Q, FU871Q, FU429Q, FUPQ, FVQ, FUQ, FSQ, KEP001Q)
- Registration date
- September 26, 2023
- Expiry date
- September 26, 2028
- Source update date
- March 19, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Da Hon Enterprises Company Limited
- Manufacturer
- Assut Europe SPA
Official description
Sutures, Synthetic, Absorbable, Poliglecaprone
Additional source fields
- AMD nomenclature code
- 20884
- Traditional Chinese local responsible person
- 達康企業有限公司
- Local responsible person phone
- 27590638
- Published manufacturer address
- Via Giuseppe Gregoraci, 12-00173 Roma
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.