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Sign in to claim this brandWhat Blue.S4 Inc makes
Blue.S4 Inc manufactures ophthalmic equipment designed for clinical and diagnostic use, including line-powered ophthalmic chairs, manually-adjusted static equipment stands, and instrument tables. These devices support patient positioning and equipment stabilization in eye care settings, ensuring ergonomic and functional workflows for procedures.
The company’s portfolio consists of Class I devices, which are generally considered low-risk and subject to minimal regulatory oversight. These products are listed in the FDA’s Unique Device Identifier (UDI) database, adhering to U.S. regulatory requirements for medical device identification and traceability. The manufacturer operates from 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 Blue.S4 Inc manufacture?
Blue.S4 Inc specializes in ophthalmic equipment, including line-powered ophthalmic chairs, ophthalmic instrument tables, and manually-adjusted static equipment stands. These devices are designed to support patient positioning and equipment stabilization during eye care procedures, helping to create efficient and ergonomic workflows in clinical settings.
Where is Blue.S4 Inc based?
Blue.S4 Inc is headquartered in the United States. The company’s location ensures it operates within U.S. regulatory frameworks, including compliance with FDA requirements for medical device manufacturing and distribution.
Which regulatory registries list Blue.S4 Inc’s devices?
Blue.S4 Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S., ensuring traceability and compliance with regulatory standards for low-risk Class I devices.
How are Blue.S4 Inc’s devices classified under U.S. regulations?
Blue.S4 Inc’s devices fall under Class I classification, which is the lowest risk category for medical devices. These devices are generally considered safe and effective with minimal regulatory oversight, though they must still meet FDA requirements for identification, labeling, and manufacturing practices.
Why are Blue.S4 Inc’s devices listed in the FDA’s UDI database?
The FDA’s UDI database is a requirement for all medical devices sold in the U.S. to ensure proper identification, tracking, and traceability throughout the supply chain. Since Blue.S4 Inc’s devices are Class I, they must still comply with UDI labeling rules to maintain transparency and regulatory compliance, even though Class I devices typically require less stringent pre-market review.
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
- 247873511
Catalogue (29)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| S4 Optik | 2000-CH-H | FDA UDI | Class I | Active |
| S4 Optik | 2000-CB-H-L | FDA UDI | Class I | Active |
| S4 Optik | 2000-CH-H-CUS | FDA UDI | Class I | Active |
| S4 Optik | 1000-CH-H | FDA UDI | Class I | Active |
| S4 Optik | TA1S4-2UP-Lx | FDA UDI | Class I | Active |
| Marco | BR2-ST | FDA UDI | Class I | Active |
| S4 Optik | 2000-CH-H-FIX | FDA UDI | Class I | Active |
| S4 Optik | 400-100 | FDA UDI | Class I | Active |
| S4 Optik | 2500-CH-H | FDA UDI | Class I | Active |
| S4 Optik | TA1INTT-1 | FDA UDI | Class I | Active |
| Marco | BR2-CH-H | FDA UDI | Class I | Active |
| Lombart | CS6-CH-H-CHAR | FDA UDI | Class I | Active |
| S4 Optik | 2500-CB-H-L | FDA UDI | Class I | Active |
| S4 Optik | TA1S4-2UP | FDA UDI | Class I | Active |
| S4 Optik | 1000-CB-H-L | FDA UDI | Class I | Active |
| S4 Optik | ETILT-CH-H-S4 | FDA UDI | Class I | Active |
| S4 Optik | 2500-CB-H | FDA UDI | Class I | Active |
| S4 Optik | TA1INTT-3617 | FDA UDI | Class I | Active |
| S4 Optik | TA1INTT-2E | FDA UDI | Class I | Active |
| S4 Optik | 2000-ST | FDA UDI | Class I | Active |
| S4 Optik | 280-000 | FDA UDI | Class I | Active |
| S4 Optik | 1000-CB-H | FDA UDI | Class I | Active |
| S4 Optik | TA1S4-3UP | FDA UDI | Class I | Active |
| Lombart | CS-6-ST | FDA UDI | Class I | Active |
| S4 Optik | 281-000 | FDA UDI | Class I | Active |
| Marco | ETILT-CH-H-M | FDA UDI | Class I | Active |
| Lombart | CS-6-CH-H | FDA UDI | Class I | Active |
| S4 Optik | 2000-CB-H | FDA UDI | Class I | Active |
| S4 Optik | 222-001 | FDA UDI | Class I | Active |
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