Xiamen Creator Technology
| Payment Terms | T/T, L/C, PayPal, Western Union |
| Supply Ability | 100000 Pieces per Month |
| Delivery Time | 25-35 working days for new mold, 7-15 days for production |
| Packaging Details | Export-grade carton with PE bag, palletized for container shipment |
| Cleanroom Class | ISO Class 8 (100,000) |
| Validation | IQ/OQ/PQ Protocol |
| Brand Name | Creator |
| Model Number | KD-MED-001 |
| Place of Origin | Xiamen, Fujian, China |
| Certification | ISO 13485:2016 |
View Detail Information
Explore similar products
Plastic Injection Molding Services , Single Cavity Large Red ABS Auto Parts
Plastic Injection Molding Services High Polish Surface ABS Lead Acid Battery
Sharper Housing Injection Mold / Injection Molding Service / S136 / KLM tooling
Grey Color Single Cavity Auto Parts Mould Service , Custom Plastic Injection
Product Specification
| Payment Terms | T/T, L/C, PayPal, Western Union | Supply Ability | 100000 Pieces per Month |
| Delivery Time | 25-35 working days for new mold, 7-15 days for production | Packaging Details | Export-grade carton with PE bag, palletized for container shipment |
| Cleanroom Class | ISO Class 8 (100,000) | Validation | IQ/OQ/PQ Protocol |
| Brand Name | Creator | Model Number | KD-MED-001 |
| Place of Origin | Xiamen, Fujian, China | Certification | ISO 13485:2016 |
| High Light | ISO 13485:2016 Certified Medical Plastic Injection Molding ，ISO Class 8 Cleanroom Injection Molding ，Full IQ/OQ/PQ Validation ISO 13485 Molding | ||
Certified to ISO 13485:2016, Xiamen Creator Technology Co., Ltd. provides cleanroom injection molding services for medical device components. Our ISO 13485 quality management system covers the complete product lifecycle from design validation through production, packaging, and sterilization compatibility verification.
| Certification | ISO 13485:2016, ISO 9001:2015 |
| Cleanroom Class | ISO Class 8 (100,000) |
| Mold Material | S136, NAK80, 420 Stainless Steel |
| Plastic Material | Medical-grade PC, ABS, PP, PEEK, PSU, PEI |
| Mold Precision | ±0.01mm |
| Injection Machine | 80 - 500 ton (dedicated medical line) |
| Validation | IQ/OQ/PQ Protocol |
| Sterilization | EtO, Gamma, Autoclave compatible |
Our dedicated medical injection molding workshop features an ISO Class 8 cleanroom with positive pressure, HEPA filtration, and temperature/humidity control. All production personnel follow strict gowning procedures. Our ISO 13485-certified quality system ensures complete traceability from raw material receipt through finished product release, with full validation documentation and device history records maintained for every production lot.
Q: Do you have ISO 13485 certification?
A: Yes, we are certified to ISO 13485:2016 for the design and manufacture of medical device components. Our certificate is current and available for review.
Q: What cleanroom class do you operate?
A: We operate an ISO Class 8 (Class 100,000) cleanroom with HEPA filtration, positive pressure, and controlled temperature and humidity.
Q: Can you support sterilization validation?
A: Yes. We work with materials compatible with EtO, Gamma, and Autoclave sterilization. We can coordinate with your sterilization provider for validation testing.
Q: Do you provide full device history records?
A: Absolutely. We maintain complete DHR for every production lot including material certs, process parameters, inspection records, and final release documentation.
Company Details
Business Type:
Manufacturer,Exporter,Trading Company,Seller
Year Established:
2007
Total Annual:
2000000-3000000
Employee Number:
40~50
Ecer Certification：
Verified Supplier
OEM Products manufacture for 12years, mainly focus on Plastic mold design and making, injection molding,assembly and packing. Xiamen Creator Technology has been providing the custom mold, injection molding and complete OEM products service since 2007. We work closely with our R&D engineers to i... OEM Products manufacture for 12years, mainly focus on Plastic mold design and making, injection molding,assembly and packing. Xiamen Creator Technology has been providing the custom mold, injection molding and complete OEM products service since 2007. We work closely with our R&D engineers to i...
Get in touch with us
Leave a Message, we will call you back quickly!