Name: Medical Device Assembly Machine Fully Automatic
Brand: Quanstar
Price: 1 USD

Medical Device Assembly Machine Fully Automatic

Brand Name : Quanstar

Certification : ISO

Place of Origin : Shanghai

Payment Terms : L/C,T/T

Packaging Details : wooden box

Name : Medical device assembly machine

Industry : medical

Type : fully automatic

Control system : PLC, HMI

Condition : new

Warranty : one year

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Category

Parameter

Description/Value

General Specifications

Line Length

5-30 meters (modular design)

Production Speed

50-300 pieces/min (depending on product type)

Workstation Number

5-20 stations (flexible configuration)

Power Supply

220V/380V AC, 50/60Hz

Cleanroom Compatibility

ISO Class 5-8 (optional HEPA filtration)

Assembly Module

Assembly Accuracy

±0.1 mm

Gripper Type

Medical-grade silicone/pneumatic (FDA compliant)

Ultrasonic Welding

20-40 kHz (for plastic components)

Component Size Range

5-300 mm

Inspection Module

Vision System Resolution

5-10 MP (with 10-30 μm/pixel)

Defect Detection

Particulate contamination, surface defects, dimensional accuracy

Leak Test Sensitivity

≥1 μm (for syringes, IV bags)

Sterility Verification

Optional ATP bioluminescence detection

Material Handling

Conveyor Type

FDA-approved belt/chain (anti-static options)

Positioning Accuracy

±0.2 mm

Material Compatibility

PP, PE, PVC, silicone (medical-grade)

Control System

PLC

Siemens (S7-1200/1500), Rockwell Automation

HMI

10"-15" touchscreen (21 CFR Part 11 compliant)

Traceability System

Barcode/RFID (UDI compliance)

Data Integrity

Audit trail, electronic signatures (GMP requirements)

Quality Metrics

False Rejection Rate

≤0.1%

First-Pass Yield

≥99.8%

AQL Level

0.65 (standard sampling plan)

Environmental

Operating Temperature

18-26°C (controlled environment)

Humidity Range

30-60% RH

Noise Level

≤65 dB

Safety & Compliance

Regulatory Standards

ISO 13485, FDA 21 CFR Part 820, EU MDR

Safety Features

Emergency stop, interlocks, cleanroom-grade materials

Validation Package

IQ/OQ/PQ documentation available

Medical Device Assembly Machine Fully Automatic

FAQ

1.Q: Are you trading company or manufacturer?
A: We are a manufacturer with over 10 years of production and development experience.

2.Q: What are your major products?
A: We are an assembly automation solution provider specialized in customized automatic machinery for production. For example, we provide customized asembly line, testing and packaging solutions to several electric vehicle (EV) manufacturers, such as component-level lines for battery packs, thermal management systems, steerings and so on.

3. Q: How long is your delivery time?
A: Usually 3 months is a production cycle, the specific delivery date should be arranged according to the product’s complexity and real-time production schedule. Please contact us for the latest delivery date.

4.Q: How about your price?
A: Show us your parts and we will be glad to find solutions and provide a suitable scheme, and offer the most competitive price to you.

5.Q: What is your terms of payment ?
A: 40% deposit and 60% balance payment before delivery.

6.Q: What is the package for you machine?
A: We have standard wooden case package.

7.Q: How long is the warranty?
A: Our aftersale service is one year free warranty, and life-time maintenance guaranteed.

8.Q:What partners do you work with?

A: We can both work with customer’s designated partners and propose other components partners at customer’s request. Some of our technical partners as below:

Fully Automatic Medical Device Assembly Machine