What certifications does the product have?

The product holds ISO 13485 and CE certifications, with manufacturing validated under EN ISO 11607.

What is the warranty period?

The quality guarantee period for these sterilization pouches is two years.

How should the pouches be sealed?

They can be sealed mechanically or manually with a heat sealer, ensuring a 50/50 adhesive bond on paper and plastic.

Flat Sterilization Pouches

Name: Flat Sterilization Pouches
Brand: Zhucheng Binfei Medi-Tek Co., Ltd.
SKU: 2051652102

Shandong, ChinaZhucheng Binfei Medi-Tek Co., Ltd.

US$1.30-2.00

2,000 box

Sample price:US$2.00/box.Request sample

Product profile

Customization

Available

Type

Paper+PE

Material

Plastic

Model NO.

BF-SP

Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

All

Logo Printing

Without Logo Printing

Sterile

Eo or Steam

Colors

Blue, Green, White etc.

Size

70X260mm

OEM

Available

ODM

Available

Transport Package

200pouches/Box

Specification

70*260mm and more

Trademark

BINFEI

Origin

China

HS Code

3005109000

Production Capacity

250000PCS/Day

Key features

Dual Sterilization Compatibility: Suitable for both steam and ethylene oxide (EO) gas sterilization processes.

Process Indicator Accuracy: Water-based, non-toxic indicators meet ISO 11140-1 for clear color change verification.

Customizable OEM/ODM: OEM and ODM services available for colors, sizes, and sterile methods (Eo or Steam).

FDA Approved Medical Device: Approved by FDA to sterilize equipment and protect tools against contamination.

ISO 13485 & CE Certified: Manufacturing processes validated under EN ISO 11607 with ISO 13485 certification.

Easy Seal Design: Features a thumb notch and self-sealing adhesive for airtight protection of instruments.

Company profile

Zhucheng Binfei Medi-Tek Co., Ltd.

Shandong, China

Business Type: Manufacturer/FactoryExport Year: 2018-05-01Nearest Port: Qingdao, ShanghaiAverage Response Time: ≤4.53hTerms of Payment: LC, T/T, D/P, etc.International Commercial Terms(Incoterms): FOB, EXW, CFR, CIF, FAS, DDP, DAP, FCA

AI-Powered supplier vetting

SummaryZhucheng Binfei Medi-Tek Co., Ltd. is identified as a manufacturer/factory in Shandong, China, offering disinfection products, PPE, medical consumables, and dental products. It reports more than 10 production lines, 6–10 quality-control staff, ISO 13485 certification, OEM services, and exports to multiple global regions. Reported standard lead times are within 15 working days during off-peak periods and one month during peak periods. The supplier states that it has self-operated import/export rights and began exporting in 2018. Evidence supports production scale, export experience, and customization services, while after-sales capability, financial credibility, innovation strength, and specific customer cases remain insufficiently documented.

Supplier typeThe supplier is explicitly identified as a Manufacturer/Factory and Limited Company located in Shandong, China. Its listed products and business activities are concentrated in medical, PPE, disinfection, and dental consumables, indicating direct manufacturing involvement rather than a purely trading profile.

CertificationsThe supplier reports holding ISO 13485 certification, a quality-management standard relevant to medical-device production. No certificate number, issuing body, validity period, or scope is provided, so the assessment is based solely on the stated certification.

Production capacityThe supplier reports a family-owned factory alliance, strong production and delivery capability, more than 10 production lines, 6–10 quality-control staff, and lead times of within 15 working days off-season and one month during peak season. These statements support meaningful manufacturing capacity, although the reported staff experience of 4–10 years and absence of product-specific capacity data limit a fuller assessment.

Customization capabilityOEM services are explicitly offered, and the supplier states that it supports customers in different markets and aims to meet potential customer needs. This supports customization capability, although no details are given on tooling, artwork approval, minimum order quantities, sampling, or customization lead times.