DISPOSABLE HYPODERMIC NEEDLE ELECTRODE MANUFACTURED BY ALPINE BIOMED APS

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DISPOSABLE HYPODERMIC NEEDLE ELECTRODE

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	PM - Physical Medicine
FDA Product Code	IKT
FDA Classification Name	ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH
FDA Device Classification Code	Standards
FDA Regulation Number	890.1385
FDA Common Generic Name	DIAGNOSTIC ELECTROMYOGRAPH NEEDLE ELECTRODE
FDA Proprietary Device Name	DISPOSABLE HYPODERMIC NEEDLE ELECTRODE
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	AMBU A/S 6740 BAYMEADOW DR. GLEN BURNIE, MD 21060 US 457-225-2210	NEUROLINE,SUBDERMAL NEEDLE ELECTRODE	NEEDLE ELECTRODE
2	AMBU A/S RUGMARKEN 10 OLSTYKKE, 3650 DA 457-225-2210 / 457-722-52210	NEUROLINE DISPOSABLE CONCENTRIC NEEDLE ELECTRODE	CONCENTRIC NEEDLE ELECTRODE
3	AMBU SDN.BHD. LOT 69B, LINTANG BAYAN LEPAS 6 PHASE IV PENANG, 11900 MY 457-225-2210 / 45-722-52210	NEUROLINE,SUBDERMAL NEEDLE ELECTRODE	NEEDLE ELECTRODE
4	CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. KENNEWICK, WA 99336 US 509-735-6481 / 800-245-3001	ELECTRODE,MONOPOLAR EMG NEEDLE (VARIOUS)	ELECTRODE,MONOPOLAR EMG NEEDLE (VARIOUS)
5	CHALGREN ENTERPRISES, INC. 380 TOMKINS COURT GILROY, CA 95020 US 408-847-3994 / 408-847-3994	MONOPOLAR NEEDLE ELECTRODES, CONCENTRIC NEEDLE ELECTRODES	NEEDLE ELECTRODES
6	MEDTRONIC NEUROMODULATION 4000 LEXINGTON AVENUE SHOREVIEW, MN 55126 US 763-514-4000 / 763-505-0874	MULTIPLE	NEEDLE ELECTRODE
7	MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH JACKSONVILLE, FL 32216 US 763-514-4000 / 904-279-7532	MULTIPLE	VARIOUS
8	NIHON KOHDEN CORP. 31-4 NISHIOCHIAI, 1-CHOME, SHINJUKU-KU TOKYO, 161-8560 JA 81-3-5996-8000 / 81-3-5348-1721	ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH	VARIOUS EMG NEEDLES
9	ROCHESTER ELECTRO MEDICAL, INC. 15619 PREMIERE DR., SUITE 204 TAMPA, FL 33624 US 813-963-2933 / 813-963-2933	ULTRAPOINT	REFERENCE/GROUND NEEDLES, MONOPOLAR NEEDLES AND NERVE BLOCK NEEDLES
10	SP MEDICAL A/S MOLLEVEJ 1 KARISE, DK-4653 DA 45-56-766000 / 45-56-766000	MULTIPLE	NEEDLE ELECTRODE
11	TECHNOMED EUROPE AMERIKALAAN 71 MAASTRICHT AIRPORT, 6199 AE NL 31-434-086868 / 31-434-086868	NICOLET	ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH (VARIOUS TYPES)
12	THE ELECTRODE STORE, INC. 159 WEST MASON AVENUE BUCKLEY, WA 98321 US 360-829-0400 / 360-829-0400	ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH	CONCENTRIC NEEDLE ELECTRODE
13	VIASYS HEALTHCARE UK LIMITED MANOR WAY OLD WOKING, SURREY, GU22 9JX UK 847-689-8410 / 44-148-3748433	BOTOX (R) INJECTION NEEDLE	INJECTION NEEDLE
14	VIASYS NEUROCARE 5225 VERONA RD. MADISON, WI 53711 US 610-862-0800 / 608-441-2065	NICOLET	MULTIPLE