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

Umzekelo: F-Y1-A Uhlobo lwe-IIR
Isimbo: Uhlobo olucaba
Uhlobo lokunxiba: Indlebe ejingayo
Ivave: Akukho
Inqanaba lokuhluza: BFE98, Uhlobo lwe-IIR
Umbala: Blue
Umgangatho olawulayo: EN14683-2019 + AC: 2019
Inkcazo yokupakisha: 10pcs / bag, 3000pcs / CTN

Thumela i-imeyile kuthi

Iinkcukacha zeMveliso

Ulwazi

IINKCUKACHA EZONGEZELELWEYO

Ukuqulunqwa kwezinto
Inkqubo yokucoca iyilwe kwaye yalekwe ngomphezulu 25g non-elukiweyo, umaleko wesibini 25g BFE99 impahla yokuhluza, umaleko wangaphakathi 25g non-elukiweyo.

Ubungakanani besicelo
Isetyenziselwa ukugubungela umlomo, impumlo kunye nomhlathi womsebenzisi, kwaye inika umqobo womzimba wokuthintela ukuhanjiswa ngokuthe ngqo kwe-microorganisms ye-pathogenic, ulwelo lomzimba, amasuntswana, njl.

Ngaphambili: Imaski yobuso botyando (F-Y1-A Uhlobo lwe-IIR FDA510k)

Okulandelayo: Isikhundla seDome ORP-DP2 (Umqulu weChest)

I-F-Y1-A sisigqubuthelo sobuso sotyando.
Ikhowudi ye-UMDN: 12-458
Ukuhlelwa: Udidi loku-1
Umgaqo: NgokoMthetho 1, iSihlomelo V111, iSahluko III se (EU) MDR 2017/745
Indlela yokuvavanya ukuhambelana: ISIHLOMELO II + ISIHLOMELO III + Inqaku le-19 le-(EU) MDR 2017/745

Kubhengezwa ngumenzi ukuba i-F-Y1-A idibana nokubonelelwa kwe-Medical Device Regulation (EU) MDR 2017/745 yePalamente yaseYurophu kunye neBhunga le-5 ngo-Ephreli 2017 kwizixhobo zonyango.Ukuthotyelwa kwesibhengezo se-EU kusetyenziswa phantsi koxanduva lomenzi kuphela.

F-Y1-A umgangatho usetyenziswa:
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: 09 EN ISO 15223-1: 2016 ISO 10993-10:2010, EN 1041:2008