ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE MANUFACTURED BY ROCHE DIAGNOSTICS GMBH

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ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE

Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS GMBH
Address	SANDHOFER STRASSE 116
City, State, Zip	MANNHEIM,
Country	GM
FDA Owner/Operator Phone	49-621-7670
FDA Medical Specialty Code	HO - General Hospital
FDA Product Code	LZG
FDA Classification Name	PUMP, INFUSION, INSULIN
FDA Device Classification Code	Standards
FDA Regulation Number	880.5725
FDA Common Generic Name	DIABETES MANAGEMENT SOFTWARE
FDA Proprietary Device Name	ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
FDA Owner / Operator Number	9039767
FDA Owner / Operator Name	CORANGE DEUTSCHLAND HOLDING GMBH
FDA Establishment Registration Number	9610126
FDA Registered Establishment Name	ROCHE DIAGNOSTICS GMBH
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	09-27-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ROCHE DIAGNOSTICS GMBH

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	ANIMAS CORP. 200 LAWRENCE DR. WEST CHESTER, PA 19380 US 877-937-7867 / 610-644-8990 1257	PUMP, INFUSION, INSULIN	PUMP, INFUSION, INSULIN
2	BEYONICS INTERNATIONAL PTE. LTD. 30 MARSILING INDUSTRIAL ESTATE RD. 8 SINGAPORE, 739193 SN 65-634-90764 / 65-634-90601	R1000 SERIES INSULIN PUMP	INSULIN INFUSION PUMP
3	CANE S.R.L. VIA PAVIA, 105/I RIVOLI-CASCINE VICA (TORINO), 10090 IT 39-011-9574872 / 630-845-7867	MICROJET QUARK U-100	INSULIN INFUSION PUMP
4	DISETRONIC MEDICAL SYSTEMS AG KIRCHBERGSTRASSE 190 BURGDORF, 3401 SZ 041-344-242891 / 41-34-4242700	MULTIPLE (SPIRIT;D-TRONPLUS,H-TORNPLUS)	INSULIN INFUSION PUMP
5	DISETRONIC STERILE PRODUCTS, INC. 124 HERITAGE AVE. PORTSMOUTH, NH 03801 US 603-427-5511 / 603-427-5511 223	PLASTIC CARTRIDGE	VARIOUS MODELS OF STERILE PLASTIC CARTRIDGES
6	GREENWILL CO., LTD. 3F SAMHWA BLDG. 401-5 HWAGOK 7-DONG KANGSEO-GU, SEOUL, KS 82-2-26991551 / 240-683-0971	WILLCARE	INSULIN INFUSION PUMP
7	GSI ELECTRONICS 800 STEELES AVE. WEST, SUITE B10-235 THORNHILL, ON, L4J 7L2 CA 416-665-5526 / 416-665-5526	INSUJECT 2000	INSUJECT 2000
8	INSULET CORPORATION 9 OAK PARK DR. BEDFORD, MA 01730 US 781-457-4812 / 781-457-4812	OMNIPOD INSULIN MANAGEMENT SYSTEM	INFUSION PUMP
9	MEDTRONIC MINIMED 18000 DEVONSHIRE ST. NORTHRIDGE, CA 91325 US 818-362-5958 / 818-576-5616	MEDTRONIC MINIMED INFUSION PUMP	INFUSION PUMP
10	MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS, PR 00777 US 763-514-4000 / 763-505-7831	MEDTRONIC MINIMED INFUSION PUMP	INFUSION PUMP
11	SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. AVE. CALIDAD NO.4, PARQUE IND. INTERNACIONAL,OTAY UNIVERSIDAD TIJUANA, BC, 22425 MX 114-420-8-458-3232 / 619-710-1104	INSULIN INFUSION PUMP	INFUSION INSULIN PUMP
12	SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. ST. PAUL, MN 55112 US 114-420-8-458-3232 / 651-628-7240	MULTIPLE	EXTERNAL INFUSION PUMP AND ACCESSORIES
13	SOOIL DEVELOPMENT CO., LTD. 111-1, HEUKSEOKL-DONG DONGJAK-KU SEOUL, 156-071 KS / 82-2-34630041	DANA DIABECARE INSULIN PUMP,DANA DIABECARE II INSULIN PUMP	INFUSION PUMP