✓ ISO 13485 & GMPC 100K Cleanroom Direct Source Factory: Tiered MOQ (50 pcs Spot White-Label | 3,000+ pcs Custom OEM) • 7-Day Rapid Sampling
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AURAWELL MFG Verified OEM/ODM

Nighttime Recovery & Micro-Targeted Personal Care Tech Hub

AURAWELL OEM · Manufacturing

Certifications

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Visualized Industrial Hard Power

ISO 13485 & GMPC 100,000-Class Cleanroom + Connected MES Traceability

92% of Millennial and Gen-Z overseas procurement managers audit factory websites before sending an inquiry. Our facility integrates rotary medical die-cutting, automated powder/mask filling, SMT LED assembly, and full ERP/MES lot traceability.

12 Automated Lines

High-speed rotary die-cutting for H/X-shape sleep strips (500,000 pcs/day capacity).

Clean-Label Lab

100% fragrance-free, dermatologist-tested barrier repair & vegan hair powder formulations.

Optical Wavelength QC

100% spectrometer inspection for 415nm±5nm blue light wands & Low-EMF sauna blankets.

EU PPWR & US EPR Ready

Mono-material recyclable pouches & FSC-certified honeycomb paper mailers for August 2026 compliance.

Cleanroom Production Line

Live Compliance & Test Report Dossier Preview

Select any compliance standard below to inspect the factory verification scope included with your OEM shipment:

[FDA Establishment Registration & ISO 13485 Medical Device Quality System]: Covers medical-grade silicone/acrylic hypoallergenic adhesives for Mouth Tape (biocompatibility ISO 10993-5/-10 passed) and Class II 510(k)-exempt 415nm Blue Light Acne Therapy Wands. Full COA & MSDS provided per batch.