EU → North America Device Access

Philips Medizin Systeme Böblingen GmbH

DE-MF-000006026 · Germany · Böblingen

Philips Medizin Systeme Böblingen GmbH is registered in the European database on medical devices as a manufacturer, with 394 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa277
Class IIb117

Most frequent device types declared: Adult NiBP Air Hose, ComfortCare Adult & Pediatric NIBP Cuffs, DigiTrakXTPatientCable Short/Medium/Long, Efficia ECG Cables and Leadsets, Lead Set/Patient Cable/Lead Upgrade Kit.

Among these devices, 1 are declared sterile, 166 active, 127 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 394 declared devices.

Catalogue references include 867030, 989803125841, 989803157501, 989803160651, 989803166531, 989803182661.

European nomenclature codes declared: Z1203020299, Z1203020280, Z1203020285, Z12030280, Z12030201, Z1203020201.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryPhilips Medizin Systeme Boeblingen GmbH (DE) · FDA 9610816
Devices in EUDAMED394
Country of registrationGermany

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN394
Found in the U.S. device database319
Share81.0 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryPHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record72
Currently active0
Class 2 devices46
Class 3 devices26
First licensed1999-06-22

Licence types: Device Family (30), System (29), Single Device (11), Device Group Family (2).

Licensed under: PAGEWRITER TC70 ELECTRO CARDIOGRAPH, PAGEWRITER TC50 ELECTRO CARDIOGRAPH, ELECTRO CARDIOGRAPH, SOLID GEL DISPOSABLE DIAGNOSTIC ELECTRODE, ECG MANAGEMENT SYSTEMS, PHILIPS NASAL ALAR SPO2 SENSOR.

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