GASTROTRAC; POLYGRAMNET ANORECTAL FUNCTION TESTING APPLICATION MANUFACTURED BY ALPINE BIOMED APS

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GASTROTRAC; POLYGRAMNET ANORECTAL FUNCTION TESTING APPLICATION

Request for Information Form	Contact Information
Company Name	ALPINE BIOMED APS
Address	16-18 TONSBAKKEN
City, State, Zip	SKOVLUNDE,
Country	DA
FDA Owner/Operator Phone	45-44-579000
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	FFX
FDA Classification Name	SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
FDA Device Classification Code	Standards
FDA Regulation Number	876.1725
FDA Common Generic Name	GASTROINTESTINAL MOTILITY MONITORING SYSTEM
FDA Proprietary Device Name	GASTROTRAC; POLYGRAMNET ANORECTAL FUNCTION TESTING APPLICATION
FDA Owner / Operator Number	9104580
FDA Owner / Operator Name	ALPINE BIOMED APS
FDA Establishment Registration Number	3004827015
FDA Registered Establishment Name	ALPINE BIOMED APS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	07-10-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ALPINE BIOMED APS

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	BB ELECTRONICS MEDICO A/S ANE STAUNINGSVEJ 21 HORSENS, DK-8700 DA 457-625-1000 / 457-625-1000	POLYGRAF,DIGITRAPPER	GASTROINTESTIONAL MOTILITY MONITORING SYSTEM
2	CLINICAL INNOVATIONS, LLC 747 WEST 4170 SOUTH MURRAY, UT 84123 US 903-675-9321 / 801-268-8200	LATITUDE ESOPHAGEAL MOTILITY STUDY PRESSURE CATHETER AND LATITUDE ANORECTAL PRES	ESOPHAGEAL MOTILITY STUDY PRESSURE CATHETER AND ANORECTAL PRESSURE CATHETER
3	COOK ENDOSCOPY 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. WINSTON-SALEM, NC 27105 US 336-744-0157 / 336-744-0157	NO PROPRIETARY NAME LISTED	VARIOUS GASTROOINTESTINAL MOTILITY CATHETERS
4	G & J ELECTRONICS, INC. 6 DORNFELL ST. TORONTO, ONTARIO, M2R 2Y6 CA 416-733-0528 / 416-733-0528	DISTENDER SERIES II	BAROSTAT
5	KONIGSBERG INSTRUMENTS, INC. 2000 FOOTHILL BLVD. PASADENA, CA 91107 US 626-449-0016 / 626-585-4039		VARIOUS PRESSURE TRANSDUCERS FOR MEASURING GASTROINTESTINAL PRESSURE
6	KONSYL PHARMACEUTICALS, INC. 8050 INDUSTRIAL PARK RD. EASTON, MD 21601 US 410-822-5192 / 410-822-5192 132	SITZMARKS	RADIOPAQUE MARKERS
7	MEDICAL INSTRUMENTS CORPORATION, AG GLUTZ BLOTZHEIM STR. 1 SOLOTHURN, 4500 SZ / 630-690-8421	GASTROSCAN	GASTROINTESTINAL MOTILITY SYSTEMS
8	MEDICAL MEASUREMENT SYSTEMS,B.V. COLOSSEUM 25 ENSCHEDE, 7521 PV NL 315-348-03739 / 315-348-03739	MULTIPLE	VARIOUS
9	MEDICAL MEASUREMENTS, INC. 56 LINDEN ST. HACKENSACK, NJ 07601 US 201-489-9400 / 201-489-9400	GAELTEC MPR SERIES RECORDER	AMBULATORY RECORDER
10	MEDIPLUS LTD. UNIT 7 THE GATEWAY CENTRE CORONATION RD CRESSEX BUS. PK. HIGH WYCOMBE, BUCKS, HP12 35U UK 440-149-45511200 / 301-279-2899	MEDIPLUS GI MOTILITY CATHETER	MEDIPLUS GI MOTILITY CATHETER
11	MEDIWATCH UK LTD SWIFT HOUSE, COSFORD LANE, SWIFT VALLEY IND EST WARKS, CV21 IQN UK 44-178-8547888 / 44-178-8547888	ANORECTAL MANOMETRY SUITE	ANORECTAL MANOMETRY SUITE
12	MEDTRONIC NEUROMODULATION 4000 LEXINGTON AVENUE SHOREVIEW, MN 55126 US 763-514-4000 / 763-505-0874	MULTIPLE	VARIOUS TYPES OF GASTROINTESTINAL MOTILITY SYSTEMS (ELECTRICAL)
13	MUI SCIENTIFIC 145 TRADERS BLVD. EAST, #34 MISSISSAUGA, ONTARIO, L4Z 3L3 CA 905-890-5525 / 905-890-5525	PRESSURIZED INFUSION PUMP AND MOTILITY CATHETERS	GASTROINTESTINAL MOTILITY SYSTEM
14	SANDHILL SCIENTIFIC, INC. 9150 COMMERCE CENTER CIR.,#500 HIGHLANDS RANCH, CO 80129 US 303-470-7020 / 800-468-4556 1021	MULTIPLE	VARIOUS
15	SIERRA SCIENTIFIC INSTRUMENTS, INC. 5757 CENTURY BLVD. SUITE 660 LOS ANGELES, CA 90045 US 310-641-8492 / 310-641-8492	MANOSCAN, MOTILITY VISUALIZATION SYSTEM	GASTROINTESTIONAL MANOMETRY SYSTEM
16	UNISENSOR USA, INC. ONE PARK AVE. HAMPTON, NH 03842 US 41-52-3373701 / 303-234-9412	UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER	CATHETER PRESSURE TRANSDUCER