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Sign in to claim this brandSirius Medical Systems B.V.
US
Last updated May 30, 2026
What Sirius Medical Systems B.V. makes
Sirius Medical Systems B.V. manufactures implantable radiological image markers, including seed, probe, and base unit components designed for precise medical imaging guidance. These devices are used in procedures requiring real-time visualization of internal anatomical structures, such as those involving the Pintuition system.
The company’s products are classified as Class II devices under regulatory frameworks and are listed in the FDA’s 510(k) and UDI registries. The manufacturer is based 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 Sirius Medical Systems B.V. manufacture?
Sirius Medical Systems B.V. specializes in implantable radiological image markers, including seeds, probes, and base units. These devices are part of the Pintuition system, which is designed to aid in precise medical imaging guidance during procedures requiring real-time visualization of internal structures.
Where is Sirius Medical Systems B.V. based?
The company is based in the United States. This location is relevant for regulatory compliance and distribution, as it aligns with the FDA’s jurisdiction over medical devices marketed in the U.S.
Which regulatory registries list Sirius Medical Systems B.V.’s devices?
Sirius Medical Systems B.V.’s devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. These registries ensure traceability and compliance with U.S. regulatory requirements for medical devices.
How are Sirius Medical Systems B.V.’s devices classified under regulatory frameworks?
The devices manufactured by Sirius Medical Systems B.V. are classified as Class II under regulatory frameworks. This classification typically indicates moderate risk and requires compliance with specific controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
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
- 492239438
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sirius Pintuition | Sirius Pintuition Base Unit | FDA UDI | Class II | Active |
| Sirius Pintuition | Sirius Pintuition Slim Probe | FDA UDI | Class II | Active |
| Sirius Pintuition | Sirius Pintuition Seed 14G x 7cm | FDA UDI | Class II | Active |
| Sirius Pintuition | Sirius Pintuition Seed 14G x 12cm | FDA UDI | Class II | Active |
| Sirius Pintuition | Sirius Pintuition Bracket Packet 14G x 12cm | FDA UDI | Class II | Active |
| Sirius Pintuition | Sirius Pintuition Probe | FDA UDI | Class II | Active |
| Sirius Pintuition | Sirius Pintuition Bracket Packet 14G x 7cm | FDA UDI | Class II | Active |
| Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | K223682 | FDA 510(k) | Class II | Active |
| Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | K200734 | FDA 510(k) | Class II | Active |
| Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | K222643 | FDA 510(k) | Class II | Active |
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