What certifications do the sterilization pouches hold?

The products are ISO 13485 and CE certified, and the pouches themselves are ISO 11140-1 certified.

What is the packaging quantity per box and case?

There are 200 pouches per box and 20 boxes per case (carton).

Dental Self Seal Sterilization Pouches Pouch Autoclave, Sterilizer Bags

Name: Dental Self Seal Sterilization Pouches Pouch Autoclave, Sterilizer Bags
Brand: Zhucheng Binfei Medi-Tek Co., Ltd.
SKU: 2056830442

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

US$1.60-2.50

2,000 box

Sample price:US$40.00/box.Request sample

Product profile

Customization

Available

Type

Paper+PE

Material

Plastic

Model NO.

BF-SR

Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

All

Logo Printing

Without Logo Printing

Sterile

Eo or Steam

Colors

Blue, Green, White etc.

Customized

OEM Acceptable

Register Service

Available

Transport Package

200pouches/Box

Specification

90*260mm and more

Trademark

BINFEI

Origin

China

HS Code

3005109000

Production Capacity

250000PCS/Day

Key features

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

ISO 11140-1 Certified: Meets ISO 11140-1 standard with accurate, non-toxic water-based process indicators.

Customizable Colors and OEM: Colors like blue, green, white are customizable. OEM service is acceptable.

Dual Sterilization Compatibility: Suitable for both Ethylene Oxide (EO) and Steam sterilization processes.

Two Years Quality Guarantee: Comprehensive two-year quality guarantee period for all products.

Organizational Efficiency: Helps organize dental tool kits and keeps instruments in one sterile location.

Professional Factory Supply: Supplied directly from a 100,000 sqm factory in Shandong, China since 2015.

Company profile

Zhucheng Binfei Medi-Tek Co., Ltd.

Shandong, China

Business Type: Manufacturer/FactoryExport Year: 2018-05-01Nearest Port: Qingdao, ShanghaiAverage Response Time: ≤3.65hTerms 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.