Imaski yobuso bokuhlinzwa (F-Y1-A Type IIR) Isithombe Esifakiwe

Imaski yobuso bokuhlinzwa (F-Y1-A Uhlobo lwe-IIR)

Imodeli: F-Y1-A Uhlobo IIR
Isitayela: Uhlobo oluyisicaba
Uhlobo lokugqoka: Indlebe ilenga
I-Valve: Akukho
Izinga lokuhlunga: BFE98, Uhlobo IIR
Umbala: Oluhlaza okwesibhakabhaka
Izinga eliphezulu: EN14683-2019+AC:2019
Ukucaciswa kokupakisha: 10pcs/bag, 3000pcs/CTN

Thumela i-imeyili kithi

Imininingwane Yomkhiqizo

Ulwazi

ULWAZI OLWENGEZIWE

Ukwakheka kwezinto
Uhlelo lokuhlunga luklanywe futhi lwendlalwe ngobuphezulu obungama-25g obungalukiwe, ungqimba lwesibili 25g BFE99 impahla yokuhlunga, ungqimba lwangaphakathi 25g olungalukiwe.

Ububanzi besicelo
Isetshenziselwa ukumboza umlomo, ikhala nomhlathi womsebenzisi, futhi inikeza umgoqo womzimba ukuvimbela ukudluliselwa okuqondile kwama-microorganisms e-pathogenic, uketshezi lomzimba, izinhlayiya, njll.

Okwedlule: Imaski yobuso bokuhlinzwa (F-Y1-A Uhlobo IIR FDA510k)

Olandelayo: I-Dome positioner ORP-DP2 (Chest Roll)

I-F-Y1-A iyimaski yobuso bokuhlinzwa.
Ikhodi ye-UMDN: 12-458
Isigaba: Ikilasi 1
Umthetho: Ngokomthetho 1, Annex V111, Isahluko III se-(EU) MDR 2017/745
Umzila wokuhlola ukuhambisana: I-ANNEX II + ANNEX III + I-Athikili 19 ye-(EU) MDR 2017/745

Umkhiqizi umenyezelwe ukuthi i-F-Y1-A ihlangabezana nokuhlinzekwa kwe-Medical Device Regulation (EU) MDR 2017/745 yePhalamende LaseYurophu kanye NoMkhandlu wangomhla zi-5 kuMbasa 2017 kumishini yezokwelapha.Ukuvumelana kwesimemezelo se-EU kusetshenziswa ngaphansi kwesibopho somkhiqizi kuphela.

Kusetshenziswe okujwayelekile kwe-F-Y1-A:
EN ISO 13485:2016, EN ISO 14971:2012, EN 14683:2019 +AC:2019, BS EN ISO 15223-1:2016, EN ISO 10933-1:2009/AC:2010: 9-3 59, EN ISO 15223-1:2016 ISO 10993-10:2010, EN 1041:2008