Ubambe isiqinisekiso: MD 804964

kwaye isebenzisa iNkqubo yoLawulo loMgangatho ehambelana neemfuno ze-ISO 13485:2016 kulo mda ulandelayo:

Umda obhalisiweyo:

Uyilo kunye noPhuhliso, ukuVeliswa kunye noSasazo lweClips ezifakwe kwi-Sterrile Absorbable Ligation Ligation, iClip Appliers, i-implantable Disposable Multiple Polymer Ligating Clips, i-Multiple Clip Reusable Appliers, i-implantable Disposable Single Single Ligating Clips kunye ne-Single Appliers eSingle.

Uyilo kunye noPhuhliso, ukuVeliswa kunye noSasazo lwe-Disposable Sterile Biofragmentable Intestinal Staplers kunye ne-Intestine Gauges ukwenzela utyando lwamathumbu.

Umhla woBhaliso wokuqala: 30-08-2024

Umhla wokuSebenza: 30-08-2024

Umhla wohlaziyo lwamva nje: 30-08-2024

Umhla wokuphelelwa: 29-08-2027

Igama leNkampani yoMfaki-sicelo/iNombolo yelayisensi.

UStanley Co., Ltd

Idilesi yeNkampani yoMfaki-sicelo

T-6043,66, Chungmin-ro, Songpa-gu, Seoul, Riphabhlikhi yaseKorea

Igama loMenzi

IHangzhou Sunstone Technology Co., Ltd.

Idilesi yoMvelisi

Imigangatho yoku-1 kunye neyesibini, ukwakha i-2,460 Fucheng Road, isithili esitsha saseQiantang, isiXeko saseHangzhou, kwiPhondo laseZhejiang, eChina.

Udidi

Isixhobo seNkqubo yezoNyango

(Ngoko siyaqinisekisa ukuba umenzi ongentla uhambelana ne-Korea Good Manufacturing Practices of Medical Devices kwiqela lemveliso edweliswe ngasentla)

Umhla wokukhutshwa: 2023.09.27

Umhla wokuphelelwa kwexesha: 2026.09.26