Non-specific consumables for diagnostic instruments
Diagnostic registration papers
EMDN code Z1302
Manufacturers registered in Europe (EUDAMED) 20
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 51
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Medica Corp. | United States | PAQ.112X100X100BIOCARE PAQ.400X300X1000/EEG/001050 PAQ.245X300X1000/EEG/NK FV245-30 PAQ.210x140x200/QT-HS80/FX4010-FX8322 ROLLO 114X25X16I.PRINTER PAQ.210X150X300/QT80/BDCK7980 | registered |
| GRAPHIC CONTROLS ACQUISITION CORP | – | Vermed GE Healthcare | registered |
| Cardinal Health, Inc. Present in Europe in other categories | United States | Kendall non branded | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| A-M SYSTEMS, LLC | United States | Chart Paper, Thermal, for Cosmed Pony FX Spirometer Chart, X-Ref Puritan Bennett 089028 Chart, X-Ref Ohio Med 617-0020-300, 5" x 200', 8L Chart, X-Ref Puritan Bennett 4020 Chart Paper Thermal For PB900 4 9/32" x2 1/4" Chart, X-Ref Collins Apex 22023 11" x 19.625", Grn | registered |
| OWENS & MINOR DISTRIBUTION, INC. | – | MediChoice | registered |
| Welch Allyn, Inc. Present in Europe in other categories | United States | Welch Allyn, Inc. | registered |
| Fukuda Denshi USA, Inc. Present in Europe in other categories | United States | FUKUDA DENSHI | K852487 (1985) |
| Avante | – | Waveline Pro+ | registered |
| Philips Medizin Systeme Böblingen GmbH Present in Europe in other categories | Germany | Paper Avalon ECG/IUP Transducer Fetal monitoring recording paper Thermal Printer Kit, USB Avalon Toco+ MP Transducer Avalon Toco+ Transducer | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH Kendall | registered |
| Physio-Control Corp. Present in Europe in other categories | United States | 50mm x 22m ECG Printer Paper (3/roll) ECG PRINTER PAPER, 100MM ECG PRINTER PAPER 50MM CABLE, PRINTER, LP35 100mm x 22m ECG Printer Paper (2/roll) KIT, PRINTER, LP35 | K881346 (1988) |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED PATIENT MONITOR | registered |
| BOUND TREE MEDICAL, LLC | – | Curaplex | registered |
| Edan Instruments, Inc. Present in Europe in other categories | China | Patient Monitor | registered |
| Philips Medical Systems Hsg | – | Paper | registered |
| Draeger Medical Systems, Inc. Present in Europe in other categories | United States | SHP UNT R50 RECORDER UNIVERSA INFINITY R50-N RECORDER Infinity R50-S Recorder | registered |
| Bio/Data Corp. Present in Europe in other categories | United States | Printer Paper Profiler Paper | registered |
| MEDSOURCE INTERNATIONAL LLC | – | MedSource Defibrillator Paper MedSource EKG Paper | registered |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | Spacelabs Healthcare Intesys Clinical Suite | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | registered |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | – | K905856 (1991) |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| MEDTRONIC PS MEDICAL, INC. | United States | – | registered |
| SKANRAY TECHNOLOGIES LIMITED Present in Europe in other categories | India | STAR 65 | registered |
| APS Trading OOD | Bulgaria | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Becton, Dickinson & CO Present in Europe in other categories | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Diagramma Dietikon AG | Switzerland | – | registered |
| Dykam Ein Harod Meuhad ACA Ltd. | Israel | – | registered |
| ENDONEST MEDICAL SYSTEMS LLP | India | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| GERMAINE LABORATORIES, INC | United States | – | registered |
| ISD MEDITECH SDN. BHD. Present in Europe in other categories | Malaysia | – | registered |
| KIMBALL SOLUTIONS GROUP, LLC | United States | – | registered |
| Little Doctor Electronic (Nantong)Co.,Ltd | China | – | registered |
| Maquet Critical Care AB Present in Europe in other categories | United States | – | registered |
| NICOLAY GMBH | Germany | – | registered |
| Orantech Inc. Present in Europe in other categories | China | – | registered |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | – | registered |
| SHANGHAI LIONS INDUSTRIAL CO.,LTD. | China | – | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Schiller AG Present in Europe in other categories | Switzerland | – | registered |
| Shanghai Jolly Industrial Co., Ltd. Present in Europe in other categories | China | – | registered |
| Spacelabs Healthcare Present in Europe in other categories | United States | – | registered |
| SunMed Group Holdings, LLC dba AirLife | United States | – | registered |
| Tele-Paper (M) Sdn Bhd | Malaysia | – | registered |
| XIAMEN MK HEALTH CARE PRODUCT CO., LTD. | China | – | registered |
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