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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 11 of 13| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Rollo 55x40x16e.he(etoile) | 1005503 | FDA UDI | Class I | Active |
| Paq.420x300x500 /eeg/000010 | 2442005 | FDA UDI | Class I | Active |
| Paq.90x90x360.microsmart.(mx) | 2909005 | FDA UDI | Class I | Active |
| Rollo 183x30x19e.cr-Kenz(lm) | 1018301 | FDA UDI | Class I | Active |
| Paq.317x300x1000/Eeg/000000. | 2431700 | FDA UDI | Class I | Active |
| Rollo 80x15x12e*31*printer | 1008006 | FDA UDI | Class I | Active |
| Paq.350x300x1000/Eeg/101000 | 2435000 | FDA UDI | Class I | Active |
| Paq.155x300x1000/Eeg/140011gr | 2415502 | FDA UDI | Class I | Active |
| Rollo 63x30x16i.oem Bexen Xeg107a | 1006322 | FDA UDI | Class I | Active |
| Rollo 120x20x19e/K360/Ar1200 | 1012007 | FDA UDI | Class I | Active |
| Rollo 63x30x16i.fk-Nk(2mm) | 1006311 | FDA UDI | Class I | Active |
| Rollo 80x30x25e*31*printer | 1008007 | FDA UDI | Class I | Active |
| Paq.345x300x1000/Eeg/001001cc | 2434515 | FDA UDI | Class I | Active |
| PAQ.243x300x1000/EEG/ | 2424301 | FDA UDI | Class I | Active |
| Rollo 144x27x16i*31*fn-Nk.3c | 1014407 | FDA UDI | Class I | Active |
| Rollo 142x30x19e*n3*ote.c3p. | 1014200 | FDA UDI | Class I | Active |
| Rollo 144x30x16i/Nk(letoile) | 1014415 | FDA UDI | Class I | Active |
| Rollo 112x30x12i/Qt-Hs/Bcm600 | 1011217 | FDA UDI | Class I | Active |
| Rollo 60x30x16e.dlt1(gaesca) | 1006027 | FDA UDI | Class I | Active |
| Paq.423x300x1000/Eeg/000010 | 2442300 | FDA UDI | Class I | Active |
| Paq.215x280x300/Qt.hs80/Case-12.1p Green | 3021510 | FDA UDI | Class I | Active |
| PAQ. 110x140x140/QT-HS/ FX7202 | 2911009 | FDA UDI | Class I | Active |
| Paq.408x300x1000/Eeg/110010 | 2440800 | FDA UDI | Class I | Active |
| Paq.50x70x400*31*fukuda.mn. | 2905000 | FDA UDI | Class I | Active |
| Paq.330x300x1000/Eeg/000010. | 2433000 | FDA UDI | Class I | Active |
| Rollo 80x30x12e.printer | 1008004 | FDA UDI | Class I | Active |
| Paq. 112x100x300 Delta 3+ -oem Et Medic | 2911210 | FDA UDI | Class I | Active |
| ROLLO 112x25x16E/QT-HS/DELTA 3+ | 1011222 | FDA UDI | Class I | Active |
| Rollo 110x30x16e. | 1011020 | FDA UDI | Class I | Active |
| Paq.345x300x1000/Eeg/001010. | 2434500 | FDA UDI | Class I | Active |
| Rollo 112x25x12e/Qt-Hs/Printer (sin Fin) | 1011207 | FDA UDI | Class I | Active |
| Rollo 104x40x16e*31*ascard-3p | 1010401 | FDA UDI | Class I | Active |
| Rollo 216x60x16e*31*n.kohden. | 1021604 | FDA UDI | Class I | Unknown |
| Paq.50x100x300*31*fqw50-3-100 | 2905004 | FDA UDI | Class I | Active |
| ROLLO 152x25x12I/QT-HS/BIONET FC1400 | 1015200 | FDA UDI | Class I | Active |
| ROLLO 80x20x16E/QT-HS/CM300 | 1008012 | FDA UDI | Class I | Active |
| Paq.210x300x500 /eeg/100000 | 2421009 | FDA UDI | Class I | Active |
| Rollo 37x20x12e.printer | 1003704 | FDA UDI | Class I | Active |
| Rollo 57x120x25i.printer | 1005714 | FDA UDI | Class I | Active |
| Rollo 210x30x19e*31*suz-Kenz. | 1021006 | FDA UDI | Class I | Active |
| Rollo 60x125x25e.printer. | 1006014 | FDA UDI | Class I | Active |
| Paq.70x100x200*31*sch.at-3.mn | 2907000 | FDA UDI | Class I | Active |
| Rollo 63x45x16i.sa (lm) | 1006314 | FDA UDI | Class I | Active |
| Rollo 215x50x19e/Qt-Hs80/Eli200 Mn | 1021501 | FDA UDI | Class I | Active |
| Rollo 63x30x16i.fk.(mes) | 1006315 | FDA UDI | Class I | Active |
| Rollo 60x25x12e*31*printer. | 1006000 | FDA UDI | Class I | Active |
| Rollo 57x100x25e.farmatec | 1005715 | FDA UDI | Class I | Active |
| Rollo 60x30x16e*31*delt1 Plus | 1006006 | FDA UDI | Class I | Active |
| Rollo 50x30x16i.fk(comindent) | 1005035 | FDA UDI | Class I | Active |
| Rollo 57x25x12e*31*printer. | 1005701 | 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