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Sign in to claim this brandHERAEUS MEDICAL COMPONENTS LLC
United States·US-MF-000018306
Last updated May 25, 2026
What HERAEUS MEDICAL COMPONENTS LLC makes
The company manufactures manual and single-use guidewires for peripheral and cardiac/peripheral vascular procedures, including specialized types for gastro-urological applications. It also produces peripheral vascular intervention infusion catheters, vascular microcatheters, and kits for extracting or repositioning vena cava filters. Examples include ERCP guidewires, vascular access guidewires like the Spring Coil Guidewire and Selectiva, and the Poseidon catheter.
The portfolio includes devices classified under FDA categories Class I, Class II, Class IIa, and Class III, with some entries listed in the EU’s EUDAMED registry and FDA’s 510(k) and UDI databases. 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 Heraeus Medical Components LLC manufacture?
Heraeus Medical Components LLC specializes in guidewires and related vascular devices. Their portfolio includes manual and single-use guidewires for peripheral and cardiac/peripheral vascular procedures, such as the Spring Coil Guidewire and Selectiva. They also produce specialized gastro-urological guidewires, peripheral vascular intervention infusion catheters (e.g., Poseidon), vascular microcatheters, and kits for extracting or repositioning vena cava filters. These devices are designed for interventional radiology, cardiology, and gastroenterology applications.
Where is Heraeus Medical Components LLC based?
Heraeus Medical Components LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.
Which regulatory registries list devices manufactured by Heraeus Medical Components LLC?
Devices from Heraeus Medical Components LLC are listed in multiple regulatory databases, including the EU’s EUDAMED registry for European Union compliance tracking. In the U.S., their devices appear in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system, which catalogs medical devices for identification and traceability purposes.
How are the devices manufactured by Heraeus Medical Components LLC classified under U.S. regulations?
Heraeus Medical Components LLC’s devices fall into various FDA classification categories depending on their risk level and intended use. Their portfolio includes Class I (low-risk) devices like some guidewires, Class II (moderate-risk) devices such as infusion catheters and microcatheters, Class IIa (a subset of Class II with specific regulatory controls), and Class III (high-risk) devices, which require premarket approval due to their critical role in patient safety or efficacy. Classification is determined by the FDA based on factors like procedure invasiveness and potential harm.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 5030 Centerville Road, St. Paul, United States
- Website
- heraeus.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Juliana Vaz Nuernberger
- EUDAMED SRN
- US-MF-000018306
- FDA FEI Number
- —
- DUNS Number
- 080645456
Catalogue (154)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ercp | GI130 | FDA UDI | Class II | Active |
| Ercp | GI126 | FDA UDI | Class II | Active |
| Tmw | SP-4091-106 | FDA UDI | Class II | Active |
| Ercp | GI111 | FDA UDI | Class II | Active |
| Selectiva | 1818004S | FDA UDI | Class II | Active |
| Ercp | GI113 | FDA UDI | Class II | Active |
| Vascupuncture | 14080705TW | FDA UDI | Class II | Active |
| Vascupuncture | 16130613TW-05MPA | FDA UDI | Class II | Active |
| Vascupuncture | 18080280NW-05MPS | FDA UDI | Class II | Active |
| Motion Hybrid Wire Guide | MHWA-038150 | FDA UDI | Class I | Active |
| Selectiva | 3518004S-SB | FDA UDI | Class II | Active |
| Selectiva | 3518004S | FDA UDI | Class II | Active |
| Arrow Marked Guidewire | PW-18130-HN | FDA UDI | Class II | Active |
| NeoWire | SP-4089-117 | FDA UDI | Class II | Active |
| Ercp | GI121 | FDA UDI | Class II | Active |
| Selectiva | 3508004S | FDA UDI | Class II | Active |
| SOLO PLUS Stiff Hybrid Guidewires | HW35SSJ | FDA UDI | Class I | Active |
| Motion Hybrid Wire Guide | MHWA-035150 | FDA UDI | Class I | Active |
| Arrow Marked Guidewire | PW-18080-HS | FDA UDI | Class II | Active |
| Ercp | GI124 | FDA UDI | Class II | Active |
| Vascupuncture | 18080360NW-65MPK | FDA UDI | Class II | Active |
| Selectiva | 3514504S | FDA UDI | Class II | Active |
| Selectiva | 3530004A | FDA UDI | Class II | Active |
| Selectiva | 18060280NW-ASL | FDA UDI | Class II | Active |
| Tmw | SP-4091-105 | FDA UDI | Class II | Active |
| Spring Coil Guidewire | SCG-003 | FDA UDI | Class II | Active |
| Vascupuncture | 18070280NW-03PPS | FDA UDI | Class II | Active |
| Motion Hybrid Wire Guide | MHW-035150 | FDA UDI | Class I | Active |
| Selectiva | 1806004S | FDA UDI | Class II | Active |
| Approach Authority Workhorse Microwire Guide | AUTH-18-300 | FDA UDI | Class II | Active |
| Ercp | GI131 | FDA UDI | Class II | Active |
| NeoWire | SP-4089-100 | FDA UDI | Class II | Active |
| Vascupuncture | 16130345NW-05MPK | FDA UDI | Class II | Active |
| Ercp | GI102 | FDA UDI | Class II | Active |
| Selectiva | 3530004A-SB | FDA UDI | Class II | Active |
| Ercp | GI103 | FDA UDI | Class II | Active |
| Selectiva | 18300376NW-AFB | FDA UDI | Class II | Active |
| Bard™ Solo Flex Urology Wire (.035 NiTi, Straight) | HW35FS | EUDAMEDFDA UDI | Class IIa | Active |
| Bard™ Solo Flex Urology Wire (.038 NiTi, Straight) | HW38FS | EUDAMEDFDA UDI | Class IIa | Active |
| Bard™ Solo Plus Urology Wire (.038 Triton, Straight) | HW38SS | EUDAMEDFDA UDI | Class IIa | Active |
| Bard™ Solo Flex Urology Wire (.035 NiTi, Angled) | HW35FA | EUDAMEDFDA UDI | Class IIa | Active |
| Bard™ Solo Hydro Urology Wire (.035 Triton, Straight) | HW35HS | EUDAMEDFDA UDI | Class IIa | Active |
| Hereaeus Poseidon Microcatheter | K191305 | FDA 510(k) | Class II | Active |
| Odyssey Micro Catheter | K170664 | FDA 510(k) | Class II | Active |
| Heraeus Peripheral Guidewire | K191502 | FDA 510(k) | Class II | Active |
| Heraeus TMW Guidewire | K173052 | FDA 510(k) | Class II | Active |
| Bard™ Snare Retrieval Kit | SRK35 | EUDAMEDFDA UDI | Class III | Active |
| Bard™ Solo Plus Urology Wire (.038 Triton, Angled) | HW38SA | EUDAMEDFDA UDI | Class IIa | Active |
| Bard™ Solo Hydro Urology Wire (.038 Triton, Angled) | HW38HA | EUDAMEDFDA UDI | Class IIa | Active |
| Bard™ Solo Plus Urology Wire (.035 Triton, Angled) | HW35SA | EUDAMEDFDA UDI | Class IIa | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Heraeus Medical Components, SRL Guadalupe Cartago · CR FEI 3013666336