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Ẹnikẹni ti o wa labẹ ọjọ-ori 21 ti ni eewọ lati ra e-siga.

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OHUN PMTA

OHUN PMTA

PMTA (Ohun elo Taba Premarket) tumọ si pe lẹhin Kínní 15, 2007, atokọ ofin ti eyikeyi ọja taba tuntun nilo ifọwọsi FDA. Ile-ibẹwẹ nilo lati ronu boya ọja yii jẹ anfani si ilera gbogbogbo.

Awọn Pataki wa

Lẹhin igbaradi iṣẹ akanṣe ati iwadii, WOOMI fi PMTA kan silẹ si FDA ṣaaju Oṣu Kẹwa Ọjọ 3, Ọdun 2021.

Awọn Pataki wa

Igbesẹ 1

Project Team iṣeto
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Igbesẹ 2

Oja yiyewo
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Igbesẹ 3

Idagbasoke Ọja
Awọn Pataki wa

Igbesẹ 4

Idanwo okeerẹ
Awọn Pataki wa

Igbesẹ 5

Data Igbaradi
Awọn Pataki wa

Igbesẹ 6

Fi ohun elo silẹ

Idanwo Ọja wa

Idanwo ọja wa ṣe iwadii imọ-jinlẹ ati itupalẹ ni itupalẹ ọja ati iwadii iṣelọpọ, iwadii ti kii ṣe ile-iwosan, iwadii eniyan ti ile-iwosan ati awọn aaye ibamu miiran.

Idanwo Ọja wa
01

Ẹri Aabo Ọja

Idanwo HPHC jẹ apẹrẹ lati ṣe itupalẹ awọn paati ọja labẹ kikankikan giga ati awọn ipo lilo ti kii-giga, pẹlu HPHCs ati itupalẹ majele miiran, lati ṣe iṣiro awọn majele ati awọn ohun-ini elegbogi ti ọja ni awọn alaye, lati rii daju pe awọn paati ọja ko ni ipalara. , ati lati rii daju aabo olumulo.
02

Ẹri Aabo Ohun elo

Ninu ilana yiyan olupese ati iṣakoso ohun elo aise, ko awọn ibeere PMTA kuro lori awọn iyokuro ati awọn ayokuro lati rii daju pe olupese ati ibamu ohun elo aise. Nibayi, itọpa ti gbogbo ilana jẹ imuse, ati pe ojuse ti ọna asopọ kọọkan jẹ alaye lati rii daju didara ọja ati aabo ti awọn ohun elo aise.
03

Ẹri Aabo Itanna

ANSI/CAN/UL 8139, Awọn ọna Itanna ti Awọn Siga Itanna ati Awọn Ẹrọ Vaping, jẹ idanimọ nipasẹ Ile-iṣẹ Iṣeduro Orilẹ-ede Amẹrika (ANSI) ati Igbimọ Awọn ajohunše ti Canada (SCC), ti o bo itanna, alapapo, batiri ati awọn ọna gbigba agbara ti awọn ọja wọnyi . Idagbasoke ti UL 8139 tun ṣalaye awọn ifiyesi aabo ina kan pato ti awọn oṣiṣẹ ina ti Ariwa Amerika dide.

Digital Factory

Pese didara kilasi agbaye ati awọn ọja ailewu
WOOMI oni factory mulẹ ISO9001: 2015 ati GMP820 eto iṣakoso didara, ati idoko awọn miliọnu dọla lati ṣẹda agbegbe iṣelọpọ ti o ga julọ ati eto iṣakoso didara, eyiti o ṣe iṣeduro ni kikun iwọn ati iṣakoso oye ti apẹrẹ ati idagbasoke, awọn ohun elo aise ọja, iṣelọpọ ati iṣelọpọ , Idanwo ọja, iṣakoso didara ati awọn ilana miiran, ati pese iriri didara didara agbaye.
CLASS 100,000 IFOJUDI EKU OFO CLASS 100,000 ERUKU OFO WORKSHOP02
01

CLASS 100,000 IFOJUDI EKU OFO

2023-07-16
Ewo ni ibamu pẹlu awọn ibeere ti ISO14644-2015 (International Standard fun awọn yara mimọ ati agbegbe iṣakoso ti o ni ibatan) ati GB 50547-2019 (idiwọn apẹrẹ fun awọn yara mimọ ni ile-iṣẹ elegbogi).
wo apejuwe awọn
ACE HOTEL Mes oye Iṣakoso System
01

Mes oye Iṣakoso System

2023-07-16
MES (Eto ipaniyan iṣelọpọ) jẹ eto iṣẹ iṣakoso pq ipese ifowosowopo ti o bo iṣakoso olupese, iṣakoso aṣẹ, iṣakoso igbero, iṣakoso iṣelọpọ ati iṣakoso ifijiṣẹ.
wo apejuwe awọn
ACE HOTEL Industry-Asiwaju Aládàáṣiṣẹ
01

Industry-Asiwaju Aládàáṣiṣẹ

2023-07-16
Ile-iṣẹ oni nọmba WOOMI ṣafihan igbalode, rọrun awọn ilana apejọ lati mu ilọsiwaju iṣelọpọ ṣiṣẹ, ati ṣẹda yàrá igbẹhin, idanwo didara ọja ti o muna, ati rii daju aabo ọja ati igbẹkẹle.
wo apejuwe awọn
ACE HOTEL Kikun Ilana Traceable Didara
01

Kikun Ilana Traceable Didara

2023-07-16
Awọn ilana mojuto 8 ti ṣeto fun iṣakoso didara, ati pe gbogbo ilana le jẹ itọpa nipasẹ iṣakoso eto MES.
wo apejuwe awọn

Ifaramo To Awujọ Ojuse

WOOMI ti nigbagbogbo fi ọja aabo ni awọn oke ti awọn oniwe-akojọ, ati ki o ti pinnu lati mu ojuse fun awọn ile ise, olumulo ati awujo. Ati WOOMI ti ṣe idoko-owo awọn miliọnu dọla lati mura PMTA ati pe yoo fi ohun elo PMTA silẹ ni deede si FDA ṣaaju Oṣu Kẹwa Ọjọ 3, Ọdun 2021.

PMTA kii ṣe idiwọ si ile-iṣẹ atomization, ṣugbọn aaye ibẹrẹ tuntun. WOOMI yoo tẹsiwaju lati ṣe atilẹyin ẹmi ti imotuntun, ni itara gba ojuse ti olutọju ti awọn ọdọ, daabobo ilera ati ailewu ti awọn olumulo olumulo agbaye, ati ṣe agbega ilana ati idagbasoke to dara ti ile-iṣẹ naa. WOOMI yoo ṣe itọsọna idagbasoke ọja pẹlu ọja ati imotuntun imọ-ẹrọ ni awọn iṣedede PMTA, ati mu iriri igbesi aye to dara julọ si awọn olumulo agbaye.