What certifications do you have?

Our factory is ISO 13485 and MDSAP certified. Most products are also CE certified.

PVC Ambu Bag Manual Resuscitator Factory with FDA, CE for Adult Size

Name: PVC Ambu Bag Manual Resuscitator Factory with FDA, CE for Adult Size
Brand: Xiamen Tianzuo Medical Co., Ltd
SKU: 1916512395

Fujian, ChinaXiamen Tianzuo Medical Co., Ltd

US$3.90-5.19

480 Pieces

Sample price:US$5.19/piece.Request sample

Product profile

Customization

Available

Material

PVC

Application

Hospital, Emergency Resuscitation Equipment

Model NO.

TW8311

Type

Emergency Resuscitation Equipment

Size

Adult Size

Certification

CE, FDA, ISO13485

Hardness

Soft

Style

Simple

Logo Printing

Without Logo Printing

Group

Adult

Feature

Disposable

Transport Package

PP Box/Color Box/PE Bag

Specification

12 sets, Carton: 55.5x34x46cm

Trademark

None

Origin

China

HS Code

9020000000

Production Capacity

100000PCS/Year

Key features

FDA and CE Certified: Compliance with European CE and American FDA standards ensures safety and quality.

ISO 13485 & MDSAP Certified: Factory holds ISO 13485 and MDSAP certifications for medical device manufacturing.

Customizable Colors: Color customization available with a minimum order quantity of 500 pieces.

OEM and ODM Support: Accepts various OEM and ODM orders including private labeling and packaging.

High-Quality Materials: Made from high-quality PVC, SEBS, or Silicone; 100% latex-free.

Reusable After Sterilization: Can be reused after sterilization by high temperature and high pressure.

Adjustable PEEP Valve: Non-Rebreathing Valve with 30mm exhale port for PEEP valve or filter.

Flexible Customization: Silicone bags can be customized in natural color under large quantity orders.

Company profile

Years of Export ExperienceSelf-brandedPatents AwardedExhibition Experience

Xiamen Tianzuo Medical Co., Ltd

Fujian, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Flexible customization CertifiedExport Year: 13 Years CertifiedNearest Port: Xiamen PortAverage Response Time: ≤7.43h

AI-Powered supplier vetting

SummaryThe supplier is a manufacturing and processing company with stated capabilities in rubber and sponge products, molds, additive manufacturing, mechanical equipment, metal products, and related sales activities. It operates two production lines in a 7,600 m² facility, has five R&D engineers, and employs 6–10 quality-control staff. The supplier reports OEM service for popular brands and offers OEM/ODM cooperation, supported by 3D printing, CNC equipment, and a clean workshop. CE certification is reported for products and sustainable-development/product certification capability, while management-system certification is listed only as “Others.” Service procedures, complaint handling, and corrective-action procedures are documented and followed. However, the supplier reports no valid manufacturing-capacity contract with associated subcontractors, no in-stock capacity, and no overseas warehouse or showroom. Financial records are indicated for 2021–2023, but no monetary figures or substantive financial metrics...

Supplier typeThe supplier is positioned as a manufacturing and processing enterprise with activities spanning rubber and sponge products, molds, additive manufacturing, mechanical equipment, metal products, electronics-related equipment, and artificial-intelligence applications. Its 7,600 m² plant and broad commercial scope support classification as a diversified manufacturer rather than a pure trading company.

CertificationsCE certification is explicitly reported for products and as sustainable-development/product certification capability. Management-system certification is recorded only as “Others,” without a named standard, so the evidence supports product compliance certification but not a clearly identified formal management-system standard.

After-Sales capabilityThe supplier has written and followed procedures for service assessment, corrective and preventive actions, and customer complaints, indicating a documented after-sales process. However, it reports no in-stock service capacity, overseas warehouse, or overseas showroom, which limits local and rapid overseas support.

R&D capabilityThe supplier reports five R&D engineers, an outstanding R&D team, 3D printers, CNC equipment, additive-manufacturing capabilities, and new products launched during the last year. Its lack of SDK availability indicates that software-development integration capability is not demonstrated, but the evidence supports product and manufacturing-oriented innovation.

Production capacityProduction resources include two production lines, a 7,600 m² manufacturing plant, CNC and 3D-printing equipment, a clean workshop, and 6–10 quality-control staff; stated peak- and off-season lead times are within 15 working days. Nevertheless, the supplier reports no valid manufacturing-capacity contract with associated subcontractors, so external capacity assurance is limited.

Customization capabilityThe supplier explicitly welcomes OEM and ODM cooperation and reports OEM service for popular brands, supported by R&D personnel, 3D printing, CNC machinery, and a clean workshop. This provides direct evidence of customized manufacturing capability, although no detailed customization scope or SDK support is available.