What certifications does the manufacturer hold?

The manufacturer is ISO 13485 certified.

Biological Indicator for Steam Sterilization Suppliers, Manufacturers

Name: Biological Indicator for Steam Sterilization Suppliers, Manufacturers
Brand: Zhucheng Binfei Medi-Tek Co., Ltd.
SKU: 2060388052

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

US$0.95-1.50

2,000 Pieces

Sample price:US$2.00/piece.Request sample

Product profile

Customization

Available

Type

Sterilization Materials

Material

Geobacilus Stearothermophilus (Atcc 7953) Spores

Model NO.

BF-B16

Ethylene Oxide Sterilization

Without Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

All

Logo Printing

With Logo Printing

Sterile

Eo or Steam

Bacteria

G. Stearothermophilus

Method

Moist Heat Sterilization

OEM

Available

ODM

Available

Content

Chemical Indicator Strip

Transport Package

25PCS/Box

Specification

ATCC7953

Trademark

BINFEI

Origin

China

HS Code

3002493090

Production Capacity

250000PCS/Day

Key features

ISO 11138 Compliance: Complies with ISO 11138-1:2017 and ISO 11138-3:2017 standards for steam sterilization.

Clear Color Change: Medium changes from purple to yellow if viable spores are present after incubation.

Specific Bacteria Strain: Uses Geobacillus stearothermophilus (ATCC 7953) spores for accurate monitoring.

OEM and ODM Available: Customization options available for sterile method, bacteria type, and content.

Two-Year Warranty: Quality guarantee period covers two years for all products.

Factory Direct Supply: Manufacturer owns a 100,000 square meter factory in Shandong, China.

ISO 13485 Certified: Manufacturer holds ISO 13485 certification for medical device quality management.

Single Use Design: Biological indicators are designed for single use and must not be reused.

Company profile

Zhucheng Binfei Medi-Tek Co., Ltd.

Shandong, China

Business Type: Manufacturer/FactoryExport Year: 2018-05-01Nearest Port: Qingdao, ShanghaiAverage Response Time: ≤2.12hTerms 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.