Medical Device Division · registration 240165ActiveEngain
Hong KongOccluders, Vascular, Intravascular Embolization, ParticulateClass IVENGAIN CO.,Ltd
Official record identity
- MDACS listing number
- 240165
- Model name
- EGgel 150-350µm (1216101), EGgel 350-560µm (1216102), EGgel 560-710µm (1216103), EGgel 710-1000µm (1216104), EGgel 1000-1400µm (1216105), EGgel 1400-2000µm (1216106), EGgel S PLUS 50-150µm (1317100), EGgel S PLUS 150-350µm (1317101), EGgel S PLUS 350-560µm (1317102), EGgel S PLUS 560-710µm (1317103), EGgel S PLUS 710-1000µm (1317104), EGgel S PLUS 1000-1400µm (1317105), EGgel S PLUS 1400-2000µm (1317106), EGgel S PLUS 2000-4000µm (1317107), EGgel S PLUS MAX (1317108)
- Registration date
- May 08, 2024
- Expiry date
- May 07, 2029
- Source update date
- July 15, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
- Published category
- Occluders, Vascular, Intravascular Embolization, Particulate
Official value: IV
Published parties
- Registrant / registration holder
- Transmedic China Limited
- Manufacturer
- ENGAIN CO.,Ltd
Official description
Occluders, Vascular, Intravascular Embolization, Particulate
Additional source fields
- AMD nomenclature code
- 20412
- Traditional Chinese local responsible person
- 傳新中國有限公司
- Local responsible person phone
- 21074668
- Published manufacturer address
- B153, B162, B163, B173, B174 and B175, The First Tower, 10, Dongtan-daero 21-gil, Hwaseong-si, Gyeonggi-do, 18471, Republic of Korea
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.