Tshiab Yug Da Dej Chaw Tsim Khoom|Sterile & Umbilical-Safe|Quanzhou Zhiyue Biotech OEM / ODM
*Kev kho mob-Qib Purity rau 0-3 Lub Hlis Cov Me Nyuam - Qhov Chaw Biotechnology ntsib Neonatal Care*
Quanzhou Zhiyue Biotechnology Co., Ltd. (ISO 13485: 2016 Medical Device Certified) pioneerstsev kho mob- tso siab rau cov ntaub so ntub cov menyuam yug tshiabrau cov khoom noj khoom haus zoo tshaj plaws thiab cov tsev kho mob maternity. Ua haujlwm raws li GMP tsis muaj menyuam, peb cov ntaub so ua tau raws li cov qauv kev xav tau siab tshaj plaws rau cov tawv nqaij yug tshiab, kev saib xyuas qaum, thiab kev tiv thaiv microbiome - txhawb nqa los ntawm kev soj ntsuam xyuas thiab kev ua raws li thoob ntiaj teb.
6 Kev Nyab Xeeb Kev Nyab Xeeb Tseem Ceeb
✅ Gamma{0}}Irradiated Sterility(ISO 11137 ua raws)
✅ pH 4.5-5.0- Sib phim kua amniotic & vernix caseosa
✅ Vernix Mimicking Complex ™- 37% muaj zog ntawm daim tawv nqaij barrier (hauv -vivo kawm)
✅ 0% Cov khoom muaj teeb meem- Tsis muaj cawv, MIT, phenoxyethanol, cov tshuaj tsw qab hluavtaws
✅ Prebiotic-Ua kom zoo- Tiv thaiv kev tsim ntawm daim tawv nqaij microbiome
✅ MOQ 20,000 units- Sterile lossis tsis yog - kev xaiv tsis muaj menyuam
Clinical -Qib Nthuav Cov Ncauj Ncauj Ncauj Ncauj
| Feature | Specification |
|---|---|
| Qib Sterility | SAL 10⁻⁶(Gamma{0}}irradiated kawg khoom) |
| Khoom siv | Kev kho mob -Qib Viscose(65gsm) los yogGOTS Organic Paj Rwb |
| Daim Ntawv Loj | 140x180mm (Perforated ∙ Silk-Tiav Edges) |
| Lotion Formula | 99.8% Ntuj Keeb Kwm: • Sterile Aqua ∙ Squalane (1.5%) • Colloidal Oatmeal (3%) ∙ Ceramide NP (0.3%) • Khaws cia: Natrulon ™ (Lactobacillus + Radish Root Ferment) |
| Tseem ceeb Exclusions | 268+ banned tshuaj (EPAA list + neonatal allergen) |
| Moisture Level | 320-350% (Precision-saturated rau cov tawv nqaij tawv) |
| Ntim | Sterile Single -Fold Packs(10-20 daim) ∙ PCR Yas Tubs nrog UV-Shield |
| Cov ntawv pov thawj | ISO 13485 ∙ MDR Annex II ∙ FDA 510 (k) Cleared ∙ EU 1223/2009 ∙ Dermatologist / Neonatologist Validated |
Cov me nyuam yug tshiab -Tshwj xeeb Innovations
CordGuard™ Technology:
pH 4.7 optimized rau umbilical stump kho
Zero rubbing cawv los yog chlorhexidine
Microbiome Shield:
Prebiotic fructooligosaccharides (FOS) tswj cov tawv nqaij pH 5.0
Txo cov kab mob pathogenic colonization los ntawm 63% (kev tshawb fawb soj ntsuam)
Tear-Kev ntxuav dawb:
Ophthalmologist - kuaj (EN ISO 10993-10 qhov muag khaus dhau)
Kev Ua Raws & Kev Xeem
BiocompatibilityTS EN ISO 10993-5/-10 (Cytotoxicity ∙ Sensitization ∙ Irritation)
Hnyav Hlau: ICP{0}}MS tested (As/Cd/Pb/Hg<0.08ppm)
Microbiological: USP<61>TS EN ISO 11737-1 Kev ruaj ntseg tsis muaj menyuam
FAQ: Me nyuam mos ntub dej so OEM
Q: Cov no puas muaj kev nyab xeeb rau NICU / menyuam mos yug ntxov?
A: Yog – validated rau 28+ lub lim tiam preemies. Formula tsis suav tag nrho EWG Qeb 3+ cov khoom xyaw.
Q: Ntev npaum li cas gamma sterilization tseem siv tau?
A: 24-hli txee lub neejnrog triple - txheej txheej barrier ntim (DIN 58363 ua raws).
Q: Kuv puas tuaj yeem hloov kho rau dej -tsuas yog cov ntaub so?
A: Yog - PebAquaPure™ sterile cov ntaub so dejdhau EP 9.0 endotoxin txwv.
Q: Koj puas txhawb nqa cov ntaub ntawv kev sib tw hauv tsev kho mob?
A: Peb muabTechnical Files ∙ Clinical Evaluation Reports (CER) ∙ MDR Annex II Docs.
Q: Dab tsi yog MOQ rau gamma - cov ntaub so ntswg sterilized?
A: 20,000 units(tsis muaj yam tsawg kawg nkaus rau cov uas tsis yog - tsis muaj menyuam).
Q: Puas yog cov khoom xyaw ua raws li Txoj Cai Tswj Kev Nyab Xeeb Me Me?
A: Tag nrho ua raws li:
California Baby Products Act (AB 1319)
EU Cov Khoom Ua Si Kev Nyab Xeeb Cov Lus Qhia 2009/48/EC
Tuam Tshoj GB/T 26572
Cim npe nrov: Me nyuam mos ntub ntaub so, Tuam Tshoj tus me nyuam mos ntub ntaub so manufacturers, lwm tus neeg, Hoobkas
