What certifications does the product hold?

The product holds CE, FDA, and ISO13485 certifications.

Is the clamp reusable?

Yes, the clamp is designed to be reusable with a strong material structure for long service life.

CT/X-ray Imaging Carbon Fiber Skull Clamp with U-Shaped Headrest for Craniotomy

Name: CT/X-ray Imaging Carbon Fiber Skull Clamp with U-Shaped Headrest for Craniotomy
Brand: Jiangsu Rooe Medical Technology Co., Ltd.
SKU: 2180835035

Jiangsu, ChinaJiangsu Rooe Medical Technology Co., Ltd.

US$9,600.00

1 Piece

Product profile

Customization

Available

Type

Surgical Clamp

Application

Neurosurgery

Model NO.

AOTA307

Material

Carbon Fiber

Feature

Reusable

Certification

CE, FDA, ISO13485

Group

Adult

Factory Location

1.5 Hours From Shanghai

Positions

Adjustable Manually

Sideways Rotation

360°

Fan-Shaped Rotation

120°

Lateral Position Fixation

90°

Transport Package

Export Carton Package

Specification

CE, ISO

Trademark

ROOETECH

Origin

China

HS Code

9018909919

Production Capacity

30 Sets/Month

Key features

Lightweight Carbon Fiber: PEEK composite structure offers 40% weight reduction with high strength and long service life.

Radiolucent Design: Compatible with CT, MRI, X-ray, and fluoroscopy without imaging artifacts for accurate navigation.

Precise Pressure Control: Equipped with pressure scale indicating system to reduce risk of intraoperative tissue damage.

Multi-Dimensional Adjustment: Supports up, down, left, right four-way adjustment with 500mm range and 500-degree tip fixation.

Modular Combination: Freely matches with extension rods, horseshoe head supports, and head nails for various surgical needs.

Reusable & Durable: Designed for repeated use with strong material properties ensuring long-term reliability.

CE, FDA, ISO13485 Certified: Meets international safety and quality standards for medical devices.

Humanized Design: Adjustable camera head support cushion and transmission lens distance improve operation convenience.

Company profile

Experienced TeamCustomization from SamplesManagement CertificationProduct Certification

Jiangsu Rooe Medical Technology Co., Ltd.

Jiangsu, China

Business Type: Manufacturer/FactoryExport Year: 2009-07-01Nearest Port: shanghai, Ningbo, QingdaoAverage Response Time: ≤2.57hTerms of Payment: LC, T/T, PayPal, etc.International Commercial Terms(Incoterms): FOB, EXW, CFR, CIF, DAT, FAS, DDP, DAP, CIP, CPT, Others, FCA

AI-Powered supplier vetting

SummaryJiangsu Rooe Medical Technology Co., Ltd. is identified as a Chinese manufacturer/factory producing hospital and medical equipment, including hospital beds, operating tables, sterilizers, stretchers, and related products. The supplier states that it maintains ISO 9001 and ISO 13485 management-system certifications, and its company description also references CE certification. Production information indicates 10 production lines and defined annual output across several product categories. The supplier has substantial export coverage, with products reportedly deployed in over 100 countries and exports accounting for 71%–90% of sales. It offers pre-sales consulting, logistics solutions, after-sales service, and personalized customization. However, the provided information does not establish detailed innovation results, financial credibility, overseas service infrastructure, or verified customer-specific cases. The SGS audit record is dated from June 2024 to June 2025, with an evaluation result recorded as 0;...

Supplier typeThe supplier is explicitly identified as a Manufacturer/Factory named Jiangsu Rooe Medical Technology Co., Ltd., based in Jiangsu, China. Its stated product scope covers hospital beds, operating tables, operating lights, sterilizers, CSSD equipment, stretchers, ICU devices, hospital furniture, rehabilitation equipment, and funeral products.

CertificationsThe supplier states that it has ISO 9001 and CE certification, while the certification record lists ISO 13485 and ISO 9001. An SGS audit record is also provided for June 27, 2024 through June 26, 2025, although the audit result is recorded as 0 without an explanation of the scoring system.

After-Sales capabilityThe company description explicitly states that it provides timely product after-sales service, professional pre-sales consulting, and logistics solutions. However, the records do not confirm overseas warehouses, showrooms, agents, or branches, so the geographic scope and depth of after-sales support remain unclear.

Production capacityThe supplier reports 10 production lines and specified annual capacities of 10,000 hospital beds, 10,000 stretchers, 2,000 operating tables, 1,000 delivery beds, and 3,000 sterilizers. It also reports an off-peak lead time within 15 workdays, providing explicit evidence of established production capacity and operational output.

Customization capabilityThe company explicitly states that it can meet customers' personalized customization requirements. The provided information does not describe the customization scope, engineering process, minimum order conditions, or examples of customized products.

Client casesThe supplier states that its products and solutions are deployed in over 100 countries and are welcomed by professional medical and hospital brokers. Its listed export markets span multiple regions, but no named customers, project references, order details, or independently verified case studies are provided.