Product Overview
The Blackhead Removal Suction Device is a portable pore cleaning system designed for controlled vacuum extraction of oil, blackheads, and impurities from facial skin.
The device is manufactured under ISO-certified production systems and complies with MDR CE medical device standards, ensuring controlled suction output and skin-contact safety consistency across mass production.
Technical Specifications
|
Parameter |
Details |
|
Power |
5W |
|
Material |
ABS + Medical Silicone |
|
Rated Voltage |
DC 5V |
|
Battery Capacity |
600mAh |
|
Size |
160×54×60mm |
|
Style |
Portable |
|
Function |
Blackhead Removal |
|
Certification |
MDR CE / CE / ISO13485 / ISO9001 / MDD CE |
|
OEM/ODM |
Supported |
Core Technology
- Adjustable 25kPa–65kPa negative pressure delivers safe, precise extraction for sensitive areas up to stubborn keratin plugs without exceeding epidermal safety thresholds.
- ISO13485-compliant manufacturing utilizes biocompatible ABS and certified skin-safe silicone nozzles to minimize allergic reactions and legal compliance risks.
- Full OEM/ODM support offers customizable colorways, private labeling, and custom packaging to meet regional retail and regulatory compliance needs.
- 40kHz ultrasonic pre-treatment uses high-frequency micro-vibrations to loosen deep-seated sebum, lowering the required mechanical suction force to protect skin.
- Stable 5W motor and 600mAh lithium battery provide up to 120 minutes of continuous runtime per charge, ensuring low defect rates and long-term reliability.
What You Get in OEM/ODM Services
- Logo Printing: High-precision laser engraving or silk-screen branding on the device body.
- Custom Packaging: OEM gift box design, customized blister trays, and localized multi-language user manuals.
- Firmware/UI Customization: Optional custom branding interface on the LED telemetry display (for high-volume contracts).
Our Seamless OEM/ODM Partnership Process
- Requirement Alignment: Discussion on branding, packaging, and technical specs (1-2 days).
- Prototyping & Sampling: Sample production with custom logos for your evaluation (3-5 days).
- Mass Production: Strict adherence to ISO13485 standards on our automated lines (25-30 days).
- Pre-Shipment Inspection: 100% pressure and battery aging testing; OQC report issuance.
- Logistics & Delivery: DDP, Air Freight, or Ocean Freight with complete customs clearance docs.
Factory Quality Control & Traceability
- 100% Automated Pressure Calibration: Every unit undergoes digital pressure-gauge verification to ensure suction levels strictly operate within the documented 25kPa to 65kPa safety limits.
- Battery Safety Protocols: All 600mAh lithium batteries pass strict aging and burn-in testing to prevent thermal issues, aligning with UN38.3 transport safety standards.
- Full Document Traceability: We provide verified corporate buyers with complete technical data sheets, raw material biocompatibility reports, and factory quality audit logs upon request.
Factory Credentials & Compliance
- Verified Manufacturing: ISO 13485:2016 Medical Devices Quality Management System & ISO 9001.
- Global Compliance: Fully certified with MDR CE, RoHS, FCC, and FDA (if applicable for target regions).
- Social Responsibility: BSCI / Sedex audited facility, ensuring ethical supply chain alignment for international retail buyers.
Packaging & Shipping Logistics
- Standard Packaging: 1 x Device, 4 x Probes, 1 x USB Charging Cable, 1 x User Manual.
- Carton Specifications: 50 units per master carton / Carton Size: 45 x 35 x 32 cm / Gross Weight: 12.5 kg.
- Palletization: Available for bulk ocean freight and Amazon FBA fulfillment standards.
FAQ
Q: Do you provide full compliance documentation for EU and US customs clearance?
A: Yes, we provide complete compliance packages upon request, including MDR CE certificates, RoHS, FCC, and MSDS/UN38.3 battery safety reports.
Q: What is your factory's standard production lead time for bulk orders?
A: Sample prototyping takes 3–5 days, while bulk mass production typically requires 25–30 days depending on the customization scope and order volume.
Q: How does your factory handle quality control and defective units (RMA)?
A: We conduct 100% functional testing on the assembly line, keeping our defect rate below 0.3%. Any verified defective units are replaced free of charge in your next shipment.
Q: Can you ship directly to Amazon FBA warehouses or provide door-to-door (DDP) logistics?
A: Yes, we regularly manage direct FBA shipping, including barcode labeling, palletizing, and full DDP/freight forwarding arrangements globally.
Q: Do you offer localized user manuals or customized language options for the packaging?
A: Yes. We provide full layout and translation support for multi-language user manuals and packaging, including English, Spanish, German, and French.
Q: What payment terms does your factory accept for high-volume B2B orders?
A: We standardly operate on a 30% T/T deposit baseline, with the remaining 70% balance due after successful quality inspection and prior to shipment loading.
