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FDA CE Certified Direct Ophthalmoscope for Fundus Examination
US$150.00
1 Piece
Product profile
Customization
AvailableClassification
Imaging Diagnostic EquipmentType
OphthalmoscopeModel NO.
Yz-11dCertification
CE, FDA, ISO13485Model
Yz-11dProduct Name
Direct OphthalmoscopeLight Source
2.6V Halogen BulbPower Supply
Built-in Rechargeable Lithium Battery + Matching CBrightness Mode
Stepless Brightness AdjustableDiopter Range
-35D ~ +20d, 24 Gears Diopter AdjustmentAperture Options
Large Spot, Small Spot, Slit, Grid, Red-Free FilteMain Material
Aluminum Alloy Handle + Medical Engineering PlastiCertificate
CE, ISO13485Warranty
1 YearCustom Service
OEM Logo, Custom Package AvailableApplication
Hospital Ophthalmology, Eye Clinic, Optometry StorPackaging
Aluminum Carry Case + Export CartonMOQ
MOQTransport Package
30*24*14cmOrigin
Jiangsu, ChinaHS Code
90185000Production Capacity
5000pieces/YearKey features
Stepless Brightness Adjustable
Rechargeable Battery with Charging Base
24 Gears Diopter (-35D~+20D)
5 Kinds of Multi-Functional Apertures
High Clear Halogen Optical Imaging
Ergonomic Comfortable Handheld Handle
Sturdy Wear-resistant Durable Structure
CE ISO13485 Medical Certified
Portable Aluminum Carry Case Included
Accept OEM Logo & Packaging Customization
Company profile
Business Type: Manufacturer/Factory, Trading CompanyAverage Response Time: ≤7.79h
AI-Powered supplier vetting
SummarySuzhou Engin Medical Technology Co., Ltd. is identified as a trading company and limited company with five employees, no affiliated group, and a valid import/export license. It offers microscope accessories and aspheric lenses, with ISO 9001 and GMP management-system certifications, five production lines, and stated output and staffing data. The supplier supports flexible, minor, full, design-based, and sample-based customization, but reports no new products during the past year, no ODM service, and no SDK. Service lead times are within 15 working days in both peak and off-seasons. Overseas support is limited: no overseas agents, branches, warehouse, showroom, or stated overseas-service countries. Service governance is weakly documented, with no written supplier-service assessment or corrective/preventive-action procedures. Financial records are indicated for 2022–2024, but no financial results are provided. No customer cases or named brand OEM experience are evidenced.
Supplier typeThe supplier is explicitly classified as a trading company and a limited company, with five employees and no affiliated company group. Its stated scope includes licensed goods and technology import/export activities, and it holds a valid import/export license.
CertificationsThe supplier reports ISO 9001 and GMP certifications, providing explicit evidence of recognized quality and manufacturing-management systems. The slices do not provide certificate numbers, scope, or validity dates, so the assessment is limited to the stated certifications.
After-Sales capabilityLead times are stated as within 15 working days in both peak and off-season, and acceptable service quotation/payment terms are specified. However, the supplier has no in-stock capacity, overseas warehouse, showroom, overseas agents or branches, and lists zero countries with overseas services; service assessment and corrective/preventive-action procedures also lack written records.
R&D capabilityThe supplier reports no new products during the past year, no ODM service, and no available SDK. Although customization is offered, these explicit limitations indicate insufficient evidence of active product innovation or software-development capability.
Production capacityThe supplier states that it operates five production lines, has an annual output range, and can achieve lead times within 15 working days in both seasons. However, it reports no in-stock capacity, while outsourcing procedures and manufacturing-capacity contracts have unknown status; overall production capability is therefore supported but not fully verifiable.
Customization capabilityThe supplier explicitly offers flexible customization, minor customization, full customization, and customization from designs or samples. This directly supports a broad customization capability, although no capacity limits or completed project evidence are provided.
Product Q&A
Q:What is the difference between YZ-11D and YZ-11 model?
A:
YZ-11D is rechargeable version with charging base and stepless brightness adjustment. YZ-11 uses disposable dry batteries with fixed brightness. YZ-11D is more suitable for long-term daily hospital use.
Q:What is the diopter adjustment range? How many gears?
A:
Diopter range: -35D ~ +20D, total 24 adjustable gears, which can meet most routine eye examinations.
Q:How many aperture modes does this ophthalmoscope have?
A:
5 apertures in total: large spot, small spot, slit, grid, red-free filter for different fundus observation needs.
Q:Is the bulb replaceable? What is the lamp specification?
A:
Yes, the halogen bulb is easy to replace. Specification: 2.6V 0.78W, spare bulbs can be provided together with order.
Q:How long is the battery working time after full charge?
A:
Fully charged battery supports continuous working for 3~4 hours, stable brightness without attenuation.
Send Inquiry
*To:
Suzhou Engin Medical Technology Co., Ltd.
Suzhou Engin Medical Technology Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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