Originally Published EMDM November
2004
Showcase
Contract manufacturing, packaging, and testing & certification |
Leak-Testing Equipment
A company offers benchtop leak-testing equipment featuring accuracy of 1 mbar,
a high-precision pressure regulator, and resident memory for four test programs.
The series also benefits from password protection, software calibration, PLC
interface, and RS-232/485 communication port for PC connection. Tecnoideal
S.r.l
 |
Catheter Production Systems
Quality, consistent results in two precision catheter production systems are ensured with temperature controlled to 1°C. Systems from the first series form complex, small-profile catheters, with heat concentrated in bands less than 1 mm. The second series is designed for large-profile catheters and multiple part tipping. SEBRA
 |
Catheter Shafts
High-performance PTFE-lined and braid-reinforced catheter shafts are offered
by a manufacturer. Constructions are available with braid or coil reinforcement,
multiple durometer jackets, bonded tips, and imbedded radiopaque markers. Typical
applications are guiding, angiographic, and stent-delivery catheters. Teleflex
Medical
 |
Loading and Transfer Systems
A manufacturer offers a full line of standard and custom-built automatic loading
and transfer systems to integrate many different types of equipment. Complete
system integration and material handling is provided for all components, from
moulding to final assembly and packaging. Kahle Europea SpA
 |
Fluid Management Products
A company designs and manufactures proprietary fluid management products such
as blood pressure connectors, luer, tube-to-tube, threaded, and bondable fittings.
More than 2800 components are available from stock and designed for use with
tubing IDs between 1¼16 in. (1.6 mm) and 1 in. (25.4 mm). Custom configurations
are also available. Value Plastics Inc.
 |
10-ml Collection Vials
Polystyrene 10-ml collection vials come with a convenient strap-attached polyethylene
screw cap. A self-standing flat bottom facilitates handling and storage. The
attached strap prevents the cap from being affixed to the wrong vial. Available
in clear or amber, the vials have a writing surface for labelling contents and
are marked to 8 ml. Qosina Corp.
 |
Coaxial Ventilator Circuit
A coaxial ventilator circuit for anaesthesia equipment and transportation is
easily accessed and is latex free. Its disposable design helps minimize the
possibility of cross-contamination between patients. Features include standard
22-mm ID and 15-mm OD connections that conform to ISO 5356-1. In addition, the
circuit conforms to ISO 5367 for leakage requirements and ISO 10993 for biocompatibility.
GaleMed Corp.
 |
Packaging Systems
Fully automated packaging systems combine high-performance standards with maximum
availability. The manufacturer emphasizes innovation in the fields of horizontal
form-film-seal machines and top loading with integral second packaging. Also
offered is a range of robotic systems. Sigpack Systems AG
 |
Modules for Medical Instruments
A manufacturer offers comprehensive methods of modules for medical instruments
and delivery of devices packed completely after their customer’s requirements.
The company also produces tubes compounded with fitting connectors and custom
formed. Materials used are certified after FDA USP Class VI. Gsell Engineering
Plastics AG
 |
Components
Among a manufacturer’s products are semifinished products such as strips,
wires, and tubes made of precious metals. The company also produces micromechanical
components made of implantable materials like titanium and precious metal alloys,
and assemblies combined with plastic. Cendres & Métaux S.A.
 |
Complex-Shaped Parts and Microassemblies
An ISO 9001:2000 and 13488:2002 TÜV-certified OEM supplies high-precision,
complex-shaped parts, and micro-assemblies in titanium and stainless steel.
Applications include implantable medical devices, minimally invasive surgery,
flexible biopsy forceps, and foreign body retrievers. Company services include
turnkey projects as well as technical support for CE certification process.
Carniaflex S.r.l.
 |
Software and Tools for Testing, Calibration
A product that calibrates and checks the efficiency of a pressure decay
leak tester can help the user select leak tester parameters. An available software
package records and prints calibration reports in conformity with ISO 9001 standards.
It is offered on CD-ROM for EURO 150. Tecna S.r.l.
 |
Rubber Parts
A company offers to meet diverse demands from the medical device industry in
the field of rubber parts for product packaging. The products conform to the
requirements of ISO 9001:2000 and ISO 13845. Seal Line S.p.A.
 |
Adhesives, Coatings, Specialty Films
A developer and manufacturer provides custom pressure-sensitive adhesives, coatings,
and specialty films for medical device applications. The range of adhesives
suitable for medical device applications includes low autofluorescence adhesives,
hydrophilic coatings, PSAs, and heat-sealable adhesive tapes. Adhesives Research
Inc.
 |
Disposable Devices and Outsourcing
A large outsource developer and manufacturer of finished, disposable medical
devices offers full product life cycle management from design to sterile goods.
The company develops and manufactures more products than any other outsourcing
company in the medical industry. Avail Medical Products Inc.
 |
Cleanroom Production
A manufacturer offers cleanroom production according to GMP classifications
C and D and certified according to DIN EN ISO 9001 and 14001 for companies active
in the pharmaceutical industry. Its product range includes highly sensitive
packaging and measuring components, caps for use in insulin products, dialysis
components, and hygiene products. B. Braun OEM/Industrial, B. Braun Medical
Inc.
Copyright ©2004
European Medical Device Manufacturer
