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Sign in to claim this brandBiosphere Medical, Inc.
US
Last updated May 23, 2026
What Biosphere Medical, Inc. makes
Biosphere Medical, Inc. manufactures embolization particles that are non-bioabsorbable, peripheral vascular guidewires that are manually operated, vascular guide-catheters designed for single-use, and non-neurovascular embolization plugs derived from animal sources.
The company's devices are classified as Class II medical devices and are listed in the FDA 510(k) database and the FDA UDI system; the company 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 Biosphere Medical, Inc. manufacture?
Biosphere Medical, Inc. manufactures embolization particles that are non-bioabsorbable, peripheral vascular guidewires that are manually operated, vascular guide-catheters designed for single-use, and non-neurovascular embolization plugs derived from animal sources. These are the device categories explicitly listed in the provided data, and no other products or functions are attributed to the company in this source.
Where is Biosphere Medical, Inc. based?
Biosphere Medical, Inc. is based in the United States, as explicitly stated in the COMPANY and COUNTRY fields of the device data. The location is given as US, which refers to the United States of America, and no other geographic details about headquarters, facilities, or operations are provided or implied.
In which regulatory registries are Biosphere Medical, Inc.'s devices listed?
Biosphere Medical, Inc.'s devices are listed in the FDA 510(k) database and the FDA UDI (Unique Device Identification) system, as stated in the LISTED IN field. These are the only two registries mentioned in the data, and no other domestic or international registries are referenced or inferred for the company's devices.
How are Biosphere Medical, Inc.'s devices classified under regulatory frameworks?
Biosphere Medical, Inc.'s devices are classified as Class II medical devices, as explicitly stated in the DEVICE CLASSES field. This classification indicates they require special controls to ensure safety and effectiveness, but it does not imply approval, clearance, or certification of the company itself—only that individual devices in these categories fall under Class II designation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- EUDAMED SRN
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- FDA FEI Number
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Catalogue (79)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Embosphere® | 00884450109854 | FDA UDI | Class II | Active |
| EmboCath® Plus | 00884450089200 | FDA UDI | Class II | Active |
| Embosphere® | 00884450299432 | FDA UDI | Class II | Active |
| Embosphere® | 00884450089323 | FDA UDI | Class II | Active |
| Embosphere® | 00884450089330 | FDA UDI | Class II | Active |
| Embosphere® | 00884450403716 | FDA UDI | Class II | Active |
| QuadraSphere® | 00884450275184 | FDA UDI | Class II | Active |
| QuadraSphere® | 00884450113875 | FDA UDI | Class II | Active |
| EmboGold® | 00884450122396 | FDA UDI | Class II | Active |
| Embosphere® | 00884450089224 | FDA UDI | Class II | Active |
| Embosphere® | 00884450403556 | FDA UDI | Class II | Active |
| Embosphere® | 00884450403402 | FDA UDI | Class II | Active |
| EmboGold® | 00884450100516 | FDA UDI | Class II | Active |
| EmboGold® | 00884450103395 | FDA UDI | Class II | Active |
| Embosphere® | 00884450403150 | FDA UDI | Class II | Active |
| Embosphere Pro™ | 00884450299449 | FDA UDI | Class II | Active |
| EmboCath® Plus | 00884450089194 | FDA UDI | Class II | Active |
| EmboGold® | 00884450097021 | FDA UDI | Class II | Active |
| Embosphere® | 00884450403457 | FDA UDI | Class II | Active |
| Embosphere® | 00884450106051 | FDA UDI | Class II | Active |
| EmboGold® | 00884450106419 | FDA UDI | Class II | Active |
| Quadrasphere 30 To 60 | K113822 | FDA 510(k) | Class II | Active |
| Embocath Plus Infusion Microcatheter, Model Ecp-100 And Ecp-135 | K062126 | FDA 510(k) | Class II | Active |
| Biosphere Medical Infusion Catheter | K003105 | FDA 510(k) | Class II | Active |
| Hepasphere Microspheres | K052742 | FDA 510(k) | Class II | Active |
| Embosphere Microspheres | K991549 | FDA 510(k) | Class II | Active |
| Sequitor Steerable Guidewire, Models Sqr18xx And Sqr14xx | K061171 | FDA 510(k) | Class II | Active |
| Embogold Microsphere | K010026 | FDA 510(k) | Class II | Active |
| Embosphere Microspheres And Embogold Microspheres For Use In Uterine Fibroid Embolization | K021397 | FDA 510(k) | Class II | Active |
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