Single Use Bite Block for Endoscopy with Adjustable Strap ISO FDA CE Approved

Name: Single Use Bite Block for Endoscopy with Adjustable Strap ISO FDA CE Approved
Brand: Zhejiang Soudon Medical Technology Co., Ltd.
SKU: 1923248741

Zhejiang, ChinaZhejiang Soudon Medical Technology Co., Ltd.

Negotiable

1,000 Pieces

Sample price:US$50.00/piece.Request sample

Product profile

Customization

Available

Type

Catheter

Material

Plastic

Model NO.

SD-bite block-03

Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

Children

Logo Printing

With Logo Printing

Shape

Round

Developing Ring

Yes

Length

2500mm

Band

with Band or Without Band

Transport Package

Protection Tube+PP Bag+Inner Box+Outer Carton

Specification

Right Pigtail

Trademark

Soudon

Origin

China

HS Code

9018903090

Production Capacity

500000PCS / Month

Key features

ISO FDA CE Approved: Certified with ISO, FDA, and CE standards for medical safety and compliance.

Adjustable Strap Design: Features an adjustable strap to improve safety and convenience during procedures.

Pediatric Options Available: Specialty disposable bite blocks designed specifically for pediatric patients.

O2 Delivery Compatibility: Purpose-built design to fit unique needs including O2 delivery endoscopy.

Ethylene Oxide Sterilized: Sterilized with Ethylene Oxide to ensure safety and hygiene for single use.

Customization Options: Offers flexible customization including shape, developing ring, and band options.

Professional Manufacturer: Direct factory with 10+ years experience and 3000 sqm dust-free workshop.

Company profile

National Award receivedFast DeliveryFull CustomizationManagement Certification

Zhejiang Soudon Medical Technology Co., Ltd.

Zhejiang, China

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: 4 Years CertifiedNearest Port: Shanghai Port, Ningbo PortAverage Response Time: ≤8.25h

AI-Powered supplier vetting

SummaryThe supplier is a combined company engaged in medical-device-related production and sales, including licensed Class II and Class III medical-device activities. It demonstrates broad customization and ODM capability, reports new-product development within the past year, and has OEM experience with well-known brands. Service procedures for corrective actions, complaints, supplier assessment, and finished-product inspection are documented and followed. However, the supplier reports no quality assurance in its quality-control processes, has only two quality-control inspectors, and lacks in-stock capacity, overseas warehouses, overseas agents or branches, and overseas service coverage. Manufacturing capacity is also weakened by the absence of a valid contract with affiliated subcontractors. Financial credibility cannot be assessed from the provided information.

Supplier typeThe supplier is identified as a combined company. Its stated business scope includes production and operation of Class II and Class III medical devices, as well as hygiene products and disposable medical supplies subject to required approvals.

After-Sales capabilityThe supplier has documented and followed procedures for corrective and preventive actions and customer complaints, and it has written procedures and records for supplier-service assessment. However, it reports no in-stock capacity, overseas warehouse, overseas showroom, overseas agent or branch, and zero countries with overseas services, limiting demonstrated international after-sales coverage.

R&D capabilityThe supplier reports new products within the past year, offers ODM services and broad design support, and holds one national science and technology progress award. Its stated emphasis on innovation is consistent with these capabilities, although it has no available SDK.

Production capacityProduction-related evidence includes assembly-line and precision-workshop facilities, two quality inspectors, standardized finished-product inspection instructions, and OEM service for well-known brands. Deficiencies include no stated quality assurance in quality-control processes, no in-stock capacity, and no valid contract with affiliated subcontractors; the business scope nevertheless includes licensed medical-device production activities.

Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, minor customization, flexible customization, and full customization. The same broad design-service range is reported in both R&D and facility-related information, providing clear evidence of extensive customization capability.

Client casesThe supplier reports OEM service for well-known brands and participation in the CMEF offline trade show. These are identifiable customer or market-exposure indicators, but no customer names, project descriptions, order volumes, or verifiable case details are provided.

Product Q&A

Q:Are you a factory or trading company?

We are a professional manufacturer which has rich experience in R&D, manufacture and sales of series endoscopic accessories like Disposable Biliary Drainage Catheter etc.

Q:What is your sample's policy and delivery time?

Our existing samples are free to provided to you, Delivery time 1-3 days; For customized samples, Cost are various according to your art work. 7-15 days for pre-production sample.

Q:How to pay for sample charges?

You can pay to our company account. When we received the sample fee, we will arrange to make the samples for you. The prepare time for sample will be 2-7days .

Q:Where is your company located?

Our company is located in Hangzhou city,Zhejiang province which is near Shanghai and Hangzhou International Airport.

Q:How does your factory do regarding quality control?

Quality is priority. We always attach great importance to quality controlling from the beginning to the end. Our factory has gained CE, ISO13485,CFDA,SGS .