Holopack Verpackungstechnik Gmbh

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Contact: Karen Jette
Web: http://www.holopack.de
E-Mail:
Address: Bahnhofstrasse, Abtsgmuend-Untergroeningen 73453, Germany
Phone: +49-(797)-6 98,800 | Fax: +49-(797)-6 1014 | Map/Directions >>

Profile: Holopack Verpackungstechnik Gmbh provides bottelpack® Blow-Fill-Seal technology for sterile filling fluid and semisolid products. Our bottelpack® system blows the bottles or vials directly sterile and free of pyrogenics using extruded PE or PP into the form the customer desires. These bottles or vials are cooled off immediately, the sterile filling goods are aseptically filled into the container & hermetically sealed.

The company is ISO 9001:2000 ,ISO 13485:2003 certified.

FDA Registration Number: 9681630
US Agent: Leena Bakhtiani / Parexel Consulting
Phone: +1-(301)-634-8010 Fax: +1-(301)-634-8040 E-Mail:

4 Products/Services (Click for related suppliers)

• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020)

Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

• Autotransfusion Apparatus (FDA Code: CAC / 868.5830)

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

• Drug Wound Dressing (FDA Code: FRO)

• Vacuum Collection Bottle (FDA Code: KDQ / 880.6740)

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).