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Silicone Mask Laryngeal Mask with CE ISO Certificate
US$2.80-3.50
2,000 Pieces
Product profile
Customization
AvailableType
Surgical Supplies MaterialsMaterial
Medical SiliconeModel NO.
ORCL-ACMEthylene Oxide Sterilization
Ethylene Oxide SterilizationQuality Guarantee Period
One YearGroup
AdultLogo Printing
Without Logo PrintingBrand & Printed
CustomizedUsage
Single-UseSize
S, M, L, XL, XXLQuality Certification
CE/ISO13485Color
White/Green/Yellow/Red/BlackService
OEM/ODMProperties
Medical Polymer Materials & ProductsFeature
Colored Removable Hook RingsDisinfecting Type
NoneSafety Standard
En166Instrument Classification
Class IIProduct Name
Laryngeal Silicone MaskShelf Life
2 YearsApplication
Surgical Operation, Emergency, HospitalCertificate
ISO13485 /CETransport Package
1PC/PE Bag, 100PCS/CartonTrademark
ORCLOrigin
Guangdong, ChinaHS Code
9018390000Production Capacity
2000 Piece/Pieces Per DayKey features
Medical Grade Material: Made of 100% medical-grade silicone or PVC, ensuring biocompatibility and safety.
Multiple Size Options: Available in sizes 1.0# to 5.0# to fit all patient groups effectively.
Certified Quality: Complies with ISO 13485 and CE standards for China, Germany, and EU markets.
Sterile Packaging: Individually packaged in paper and plastic, ethylene oxide sterilized for immediate use.
Custom Branding: Logo printing and custom packaging designs are available upon request.
Flexible Customization: Supports OEM/ODM services with customized colors, sizes, and single-use options.
Fast Sample Delivery: Sample orders are welcome with a quick lead time of 3-5 days for testing.
Low MOQ for Samples: Minimum order quantity is just 1 piece for sample checking and quality verification.
Company profile
CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 15 Years CertifiedNearest Port: Nansha PortAverage Response Time: ≤9.07h
AI-Powered supplier vetting
SummaryORCL demonstrates established medical-device quality, production, customization, and service-management capabilities. It reports EU TUV South German ISO13485 certification, EU CE (0123) certification, China NMPA registration, and China National High-tech Enterprise certification. The supplier has six quality assurance and quality control inspectors, multiple manufacturing lines, valid contracts with associated subcontractors, inventory capability, and one-month lead times in both peak and off-season periods. It supports OEM and ODM services and offers extensive customization. Service procedures for supplier approval, corrective and preventive actions, complaints, and capability assessment are documented and followed. However, the evidence also shows no available SDK, no new products in the past year, no overseas warehouse, showroom, agents, or branches, and zero stated countries for overseas services. Financial records are identified by year, but financial strength cannot be assessed from the provided...
Supplier typeThe supplier is presented as a medical-device manufacturer with its own-brand quality-control capability, OEM services for popular brands, product development and design, production-process management, and a complete medical-device product lifecycle capability. Its stated certifications and medical patents further support classification as an established medical-device supplier.
CertificationsThe supplier explicitly reports EU TUV South German ISO13485 quality management system certification, EU CE (0123) certification, China NMPA medical-device registration, and China National High-tech Enterprise certification. These certifications directly support a positive assessment for certification holding.
After-Sales capabilityThe supplier has documented and followed procedures for corrective and preventive actions, customer complaints, supplier approval, and service-capability assessment. It also reports inventory capability and one-month lead times in both peak and off-season periods, but lacks overseas warehouses, showrooms, agents, and branches; therefore, the evidence supports structured service handling but not broad overseas after-sales coverage.
R&D capabilityThe supplier reports more than 50 medical-related patents, industry-university-research cooperation, product development and design capabilities, and ODM service availability. However, it also states that no new products were developed in the past year and that no SDK is available, so the evidence supports underlying R&D resources but indicates limited recent product innovation.
Production capacityProduction evidence includes six quality inspectors, injection molding, blow molding, extrusion, packaging, spring manufacturing, and one-way valve assembly equipment, along with valid contracts with associated subcontractors and inventory capability. The supplier also reports one-month lead times in both peak and off-season periods and production-process management across the product lifecycle.
Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, full customization, minor customization, and flexible customization. It also provides ODM services, giving direct evidence of broad customization and design-manufacturing support.
Client casesThe supplier reports OEM service for popular brands and participation in the 2024 Arab Health offline trade show. These are direct examples of market-facing experience, but the slices do not identify specific customer names, order outcomes, or detailed case results.
Product Q&A
Q:Can I have a sample order?
A:
Yes, we welcome sample order to test and check quality. Mixed samples are acceptable.
Q:What about the lead time?
A:
Sample needs 3-5 days, mass production time needs 2-4 weeks for order quantity more than10,000 pcs
Q:Do you have any MOQ limit for this item?
A:
Low MOQ, 1pc for sample checking is available
Q:How do you ship the goods and how long does it take to arrive?
A:
We usually ship by DHL, UPS, FedEx or TNT. It usually takes 3-5 days to arrive. Airline and sea shipping also optional.
Q:How to proceed an order for dedical consumables?
A:
Firstly let us know your requirements or application. Secondly We quote according to your requirements or our suggestions. Thirdly customer confirms the samples and places deposit for formal order. Fourthly We arrange the production.
Send Inquiry
*To:
Guangzhou ORCL Medical Co.,LTD
Guangzhou ORCL Medical Co.,LTD*Content:
Supplier replies will be sent to your registered email
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