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Sign in to claim this brandAB MEDICA GROUP, S.A.
US
Last updated May 23, 2026
What AB MEDICA GROUP, S.A. makes
AB Medica Group produces electrocardiographic (ECG) recording paper and associated printer rolls, including standard and specialty formats for medical diagnostic equipment. Their products include rolls for ECG printers, EEG systems, and other diagnostic devices, designed to record and print physiological data.
The company’s portfolio consists of Class I medical devices, which are generally considered low-risk. These products are listed in the FDA’s Unique Device Identification (UDI) database, ensuring traceability and regulatory compliance in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does AB Medica Group, S.A. manufacture?
AB Medica Group, S.A. specializes in producing electrocardiographic (ECG) recording paper and associated printer rolls. These include standard and specialty formats designed for ECG printers, EEG systems, and other diagnostic devices that record and print physiological data. Their products are primarily consumables used in medical diagnostics.
Where is AB Medica Group, S.A. based?
AB Medica Group, S.A. is based in the United States. The company’s focus is on manufacturing medical consumables, particularly for diagnostic equipment used in healthcare settings.
Which regulatory registries list AB Medica Group’s devices?
AB Medica Group’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and compliance for Class I medical devices, which are generally considered low-risk. Listing in the UDI database helps facilitate regulatory oversight and transparency in the U.S. market.
How are AB Medica Group’s devices classified under medical device regulations?
AB Medica Group’s devices fall under Class I classification, which is the lowest risk category for medical devices. This classification is typically assigned to products like consumables (e.g., ECG recording paper) that pose minimal risk to patients and users. Class I devices are generally exempt from strict pre-market approval but still require compliance with good manufacturing practices and other regulatory requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 460037021
Catalogue (621)
Page 8 of 13| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Paq.390x300x1000/Eeg/040000 | 2439005 | FDA UDI | Class I | Active |
| Rollo 50x20x16e/Printer | 1005049 | FDA UDI | Class I | Active |
| Paq.50x100x300.nk.fps50-3-100 | 2905001 | FDA UDI | Class I | Active |
| Rollo 130x50x20i.hellige | 1013004 | FDA UDI | Class I | Active |
| Rollo 58x120x25i.printer | 1005807 | FDA UDI | Class I | Active |
| Paq.90x90x150/Qt-Hs80/Microsmart. | 2909008 | FDA UDI | Class I | Active |
| Paq.243x300x 500/Eeg/ | 2424302 | FDA UDI | Class I | Active |
| Paq.90x90x130/Qt-Hs/Zoll | 2909006 | FDA UDI | Class I | Active |
| Paq.448x300x500 /eeg/000020 | 2444802 | FDA UDI | Class I | Active |
| Rollo 118x30x16i.dr.lee. | 1011801 | FDA UDI | Class I | Active |
| Rollo 210x30x19i.mm | 1021020 | FDA UDI | Class I | Active |
| Rollo 214x20x20e/Bionet Fc700 | 1021400 | FDA UDI | Class I | Active |
| Paq.112x100x300.elan1100 | 2911207 | FDA UDI | Class I | Active |
| Paq.200x300x1000/Eeg/000000. | 2420001 | FDA UDI | Class I | Active |
| Paq.240x300x1000/Eeg/041001lp | 2424004 | FDA UDI | Class I | Active |
| Rollo 144x30x16i*31*fk-Nk.4c. | 1014404 | FDA UDI | Class I | Active |
| Rollo 80x20x19e/Qt-Hs/Meditech | 1008014 | FDA UDI | Class I | Active |
| Rollo 106x25x16i/Bexen Xeg0004a | 1010604 | FDA UDI | Class I | Active |
| Paq.210x140x160/Qt-Hs75/Schiller At-10 | 2921045 | FDA UDI | Class I | Active |
| Rollo 37x05x12e*31*printer. | 1003702 | FDA UDI | Class I | Active |
| Rollo 70x22x12e.matachana | 0507001 | FDA UDI | Class I | Active |
| Rollo 50x50x25i*31* | 1005022 | FDA UDI | Class I | Active |
| Rollo 80x40x12e.printer | 1008002 | FDA UDI | Class I | Active |
| Rollo 75x25x11, 3i.philips Mrx (plastic.) | 1007504 | FDA UDI | Class I | Active |
| Rollo 63x30x16i.fk.nk(gaesca) | 1006306 | FDA UDI | Class I | Active |
| Paq.370x300x1000/Eeg/000000. | 2437000 | FDA UDI | Class I | Active |
| Rollo 144x30x16i.4c(barasheed | 1014414 | FDA UDI | Class I | Active |
| ROLLO 112x30x16I/QT-HS/RED GRID | 1011221 | FDA UDI | Class I | Active |
| ROLLO 100x20x16E/QT-HS/ECG 100L | 1010002 | FDA UDI | Class I | Active |
| ROLLO 110x25x12E PRINTER OEM MIR 910350 | 1011023 | FDA UDI | Class I | Active |
| Paq.224x300x1000/Eeg/000010 | 2422400 | FDA UDI | Class I | Active |
| Rollo 112x25x12e.bfm900 | 1011215 | FDA UDI | Class I | Active |
| Rollo 63x30x16i.op(saudi) | 1006310 | FDA UDI | Class I | Active |
| Rollo 210x30x19e.suz-Kenz(hr) | 1021011 | FDA UDI | Class I | Active |
| Rollo 110x20x16i.contec Ecg600g | 1011022 | FDA UDI | Class I | Active |
| Rollo 50x45x16i.bd.(tecnomed) | 1005038 | FDA UDI | Class I | Active |
| Rollo 57x10x8i/Qt-Hs/Printer | 1005724 | FDA UDI | Class I | Active |
| Paq.110x140x150.fqw110-2-140 | 2911003 | FDA UDI | Class I | Active |
| Rollo 90x35x16e.hellige. | 1009003 | FDA UDI | Class I | Active |
| ROLLO 80x7, 6x12I/QT-HS/BEXEN XEG 005A | 1008019 | FDA UDI | Class I | Active |
| PAQ.420X300X1000/EEG/PASO 6mm | 2442008 | FDA UDI | Class I | Active |
| Rollo 70x25x12e/Gr60/Printer | 0507000 | FDA UDI | Class I | Active |
| Rollo 75x25x12e.printer | 1007501 | FDA UDI | Class I | Active |
| Paq.343x300x1000/Eeg/001020 | 2434303 | FDA UDI | Class I | Active |
| Rollo 63x30x16i.fk-Nk.(lm) | 1006313 | FDA UDI | Class I | Active |
| Rollo 57x130x12e*31*printer | 1005708 | FDA UDI | Class I | Active |
| Rollo 112x25x16e/Qt-Hs/Carewell | 1011216 | FDA UDI | Class I | Active |
| Rollo 114x25x12e*31*printer. | 1011400 | FDA UDI | Class I | Active |
| Paq.244x300x1000/Eeg/101010. | 2424400 | FDA UDI | Class I | Active |
| PAQ. 80x90x280/QT-HS75/ GE MAC400 | 2908001 | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Ab Medica Group S. A. Barcelona · ES FEI 1000202462