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Sign in to claim this brandOPTOMIC ESPAÑA SA
US
Last updated May 27, 2026
What OPTOMIC ESPAÑA SA makes
Optomic España SA manufactures examination and treatment systems for ear, nose, and throat (ENT) procedures, including electric ENT and general examination chairs, endoscopic and rigid optical laryngopharyngoscopes, and flexible fibreoptic nasopharyngolaryngoscopes. Their portfolio also includes otoscopes and endoscope video cameras designed for clinical use in diagnostic and procedural settings.
The company’s devices are classified under Class I in the US regulatory framework and are listed in the FDA’s Unique Device Identifier (UDI) database. Optomic España SA operates from the United States, adhering to applicable regulatory standards for these medical instruments.
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 Optomic España SA primarily manufacture?
Optomic España SA specializes in devices used for ear, nose, and throat (ENT) examinations and treatments. Their portfolio includes electric ENT and general examination chairs, otoscopes, endoscopic and rigid optical laryngopharyngoscopes, flexible fibreoptic nasopharyngolaryngoscopes, and endoscope video cameras. These devices are designed to assist clinicians in diagnostic and procedural settings, particularly for ENT procedures.
Where is Optomic España SA based, and what regulatory framework applies to their devices?
Optomic España SA is based in the United States. Their devices fall under the US regulatory classification system, specifically as Class I devices. This classification typically applies to devices posing minimal potential risk, though compliance with applicable regulations and standards remains essential for market authorization.
Are Optomic España SA’s devices listed in any regulatory databases?
Yes, Optomic España SA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps ensure traceability and transparency in the medical device supply chain, allowing for easier identification and tracking of devices in clinical and regulatory contexts.
How are Optomic España SA’s devices classified in the US regulatory system?
Optomic España SA’s devices are classified under Class I in the US regulatory framework. This classification generally applies to devices considered low-risk, such as many examination and treatment systems. However, compliance with applicable regulations—including manufacturing practices, labeling, and post-market surveillance—remains critical for market authorization.
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
- 564165678
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Optomic | OP-S9 CHAIR (STRUCTURE) | FDA UDI | Class I | Active |
| Optomic | OP-2000 HD Camera | FDA UDI | Class I | Active |
| Optomic | OP-G7+N CHAIR (FOOT SUPPORTS) | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OP-30 Naso-pharyngoscope | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OTOSCOPE OPT 4mm x 50mm x 30 | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OP-714 Camera | FDA UDI | Class I | Active |
| Optomic | OTOSMART COMPACT WORKSTATION | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OTOSCOPE OPT 2,7mm x 75mm x 0 AUT. | FDA UDI | Class I | Active |
| Optomic | OTOSMART COMPACT S WORKSTATION | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OPTIMUS WORKSTATION | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OPTIMUS EXPERT WORKSTATION | EUDAMEDFDA UDI | Class I | Active |
| Optomic | LARYNGOSCOPE OPT 6mm x 158mm x 70 AUT | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OP-G7+N CHAIR (GOEPEL) | FDA UDI | Class I | Active |
| Optomic | OP-S9 CHAIR | FDA UDI | Class I | Active |
| Optomic | OPTIMUS ELITE WORKSTATION | FDA UDI | Class I | Active |
| Optomic | LARYNGOSCOPE OPT 10mm x 158mm x 90 AUT | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OTOSCOPE OPT 1,9mm x 100mm x 0 AUT. | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OTOSCOPE OPT 2,7mm x 75mm x 30 AUT. | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OP-S4 CHAIR (STRUCTURE) | FDA UDI | Class I | Active |
| Optomic | OTOSMART PLUS WORKSTATION | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OP-S6 CHAIR (STRUCTURE) | FDA UDI | Class I | Active |
| Optomic | OP-G7+ CHAIR (FOOT SUPPORTS) | FDA UDI | Class I | Active |
| Optomic | OTOSCOPE OPT 4mm x 50mm x 0 | EUDAMEDFDA UDI | Class I | Active |
| Optomic | MICRO LARYNGOSCOPE OPT 4mm x 185mm x 70 AUT | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OTOSMART WORKSTATION | EUDAMEDFDA UDI | Class I | Active |
| Optomic | LARYNGOSCOPE OPT 10mm x 158mm x 70 AUT | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OTOSCOPE OPT 2,7mm x 75mm x 70 AUT. | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OP-S7 CHAIR (STRUCTURE) | FDA UDI | Class I | Active |
| Optomic | OP-S8 CHAIR (STRUCTURE) | FDA UDI | Class I | Active |
| Optomic | OTOSCOPE OPT 1,9mm x 100mm x 30 AUT. | EUDAMEDFDA UDI | Class I | Active |
| Optomic | OP-S10 CHAIR (STRUCTURE) | FDA UDI | Class I | Active |
| Optomic | OP-G7+ CHAIR (GOEPEL) | EUDAMEDFDA UDI | Class I | Active |
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