Is the product sterilized with Ethylene Oxide?

No, this product is without Ethylene Oxide Sterilization.

Can the product be customized?

Yes, private labeling and packaging are available as OEM/ODM services.

Reusable Silicone Resuscitator Ambu Bag Manual Hospital Medical

Name: Reusable Silicone Resuscitator Ambu Bag Manual Hospital Medical
Brand: Hangzhou Trifanz Medical Device Co., Ltd.
SKU: 2229336425

Zhejiang, ChinaHangzhou Trifanz Medical Device Co., Ltd.

US$9.50-12.00

500 Pieces

Product profile

Customization

Available

Type

Surgical Supplies Materials

Material

Silicone

Model NO.

All Size

Ethylene Oxide Sterilization

Without Ethylene Oxide Sterilization

Quality Guarantee Period

3 Years

Group

Adult,Pediatric,Neonate

Logo Printing

Without Logo Printing

Stylet

Optinal

Certification

CE Mdr, ISO 13485,FDA

OEM/ODM

Available

Oxygen Reservoir Bag

Included

Oxygen Tube

Included

Transport Package

Paper Plastic Plain Pouch/Carton

Trademark

TRIFANZ

Origin

Hangzhou, China

HS Code

9019200000

Production Capacity

5000 Pieces/Day

Key features

Medical Grade Silicone: Made of high quality medical grade silicone compliant with USA FDA standard.

100% Latex Free: Safe for patients with latex allergies, ensuring 100% latex-free material.

Reusable Design: Can be repeatedly used after sterilization by high temperature and high pressure.

Comprehensive Certification: Holds CE MDR, ISO 13485, US FDA, FSC, SGS, and COA certifications.

Complete Accessory Kit: Includes silicone face mask, oxygen tube, reservoir bag, mouth opener, and airways.

OEM/ODM Available: Private labeling and packaging customization are available for clients.

3-Year Quality Guarantee: Product comes with a 3-year quality guarantee period for peace of mind.

Factory Direct Supply: Direct supply from a factory with over 20 years of experience in Hangzhou.

Company profile

Hangzhou Trifanz Medical Device Co., Ltd.

Zhejiang, China

Business Type: Manufacturer/Factory, Trading Company, Group CorporationExport Year: 2020-03-17Nearest Port: Shanghai, Ningbo, YiwuAverage Response Time: ≤3.60hTerms of Payment: LC, T/T, PayPal, etc.International Commercial Terms(Incoterms): FOB, CFR, CIF, FAS, CIP, CPT, FCA, EXW, Others

AI-Powered supplier vetting

SummaryHangzhou Trifanz Medical Device Co., Ltd. is identified as a China-based limited company and factory/manufacturer operating in medical devices, particularly anesthesia, respiratory, and catheter products. The supplier reports ISO 13485 and ISO 9001 certification, five production lines, 6–10 R&D engineers, and 6–10 quality-control staff. It states that OEM/ODM services are available and describes export capability, with exports representing 51%–70% of sales and self-operated import/export rights. The evidence supports a relevant manufacturing profile, documented quality systems, production infrastructure, and customization availability. However, the provided information does not sufficiently establish after-sales service capability, financial credibility, or verified customer cases. The supplier’s claimed certificates beyond ISO certifications and its product and market experience are not independently substantiated in the slices.

Supplier typeThe supplier is identified as a limited company, trading company/manufacturer/factory, and group corporation in one record, while another record classifies it as a factory. Its stated operations cover R&D, production, and sales of medical anesthesia and respiratory products, with Hangzhou, China locations consistently reported.

CertificationsThe supplier explicitly reports ISO 13485 and ISO 9001 management-system certifications. It also claims ZFDA, FSC, SGS, and COA documentation, but the slices do not provide certificate numbers, validity dates, or independent verification for those additional claims.

R&D capabilityThe supplier describes itself as an innovation-oriented medical-device enterprise engaged in R&D and reports 6–10 years of total R&D engineer experience. Its stated focus includes developing anesthesia and respiration products, which supports relevant technical development capability, although no patents, laboratories, or specific innovations are provided.

Production capacityThe supplier is classified as a factory/manufacturer and reports five production lines, 6–10 quality-control staff, and a factory location in Hangzhou. Its described manufacturing scope includes disposable anesthesia and breathing products and medical catheters, providing explicit evidence of relevant production infrastructure.

Customization capabilityThe supplier explicitly states that OEM/ODM services are available and that it can provide other certificates according to a customer’s market. The slices do not define customization limits, tooling capability, minimum order requirements, or validation procedures.