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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 13 of 13| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Rollo 110x100x40, 5e/Qt-Hs/Printer | 1011024 | FDA UDI | Class I | Active |
| Paq.390x300x1000/Eeg/001001uc | 2439006 | FDA UDI | Class I | Active |
| Paq.219x300x1000/Eeg/000000 | 2421900 | FDA UDI | Class I | Active |
| Paq.356x300x500 /eeg/140011gr | 2435601 | FDA UDI | Class I | Active |
| Rollo 80x20x16i/Qt-Hs/Se508 | 1008015 | FDA UDI | Class I | Active |
| Paq.390x300x1000/Eeg/000001cb | 2439009 | FDA UDI | Class I | Active |
| Paq.210x300x1000/Eeg/000000. | 2421000 | FDA UDI | Class I | Active |
| Paq.350x300x 500/Eeg/Ink-Hs/Neur. | 2435001 | FDA UDI | Class I | Active |
| Paq.410x300x1000/Eeg/111010 | 2441003 | FDA UDI | Class I | Active |
| Rollo 108x30x16e.printer | 1010803 | FDA UDI | Class I | Active |
| Rollo 60x30x16i*31*fukuda-Nk. | 1006008 | FDA UDI | Class I | Active |
| Paq.245x300x500/Eeg/011010 | 2424516 | FDA UDI | Class I | Active |
| ROLLO 80x12x12E/QT-HS/EOLYS MINI | 1008021 | FDA UDI | Class I | Active |
| Paq.215x300x 500/Eeg/ | 2421502 | FDA UDI | Class I | Active |
| Rollo 57x100x12e*31*printer. | 1005706 | FDA UDI | Class I | Active |
| Paq.155x300x1000/Eeg/000010. | 2415500 | FDA UDI | Class I | Active |
| Rollo 144x30x16i*31*op341te | 1014406 | FDA UDI | Class I | Active |
| Rollo 55x30x16e*31*he.plain | 1005504 | FDA UDI | Class I | Active |
| Rollo 50x30x16i.fk(saudi) | 1005027 | FDA UDI | Class I | Active |
| Paq.245x300x1000/Eeg/001010. | 2424501 | FDA UDI | Class I | Active |
| Rollo 55x40x16e*31*he.plain. | 1005502 | 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