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Sign in to claim this brandBio-Med Devices, Inc.
US
Last updated September 17, 2026
About
BIO-MED manufactures some of the most reliable and accurate air-oxygen and NeO2 Blenders for ventilators on the market for the ICU, portablel applications, and more
From the manufacturer's own website. Source
What Bio-Med Devices, Inc. makes
Bio-Med Devices, Inc. produces hospital-grade oxygen/air breathing gas mixers, transport and portable electric ventilators, and battery-powered respiratory oxygen monitors designed for clinical and patient mobility use.
The company’s products are classified as Class II devices and are authorised via FDA 510(k) and UDI registrations. 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 Bio-Med Devices, Inc. manufacture?
Bio-Med Devices, Inc. specializes in hospital-grade respiratory devices, including oxygen/air breathing gas mixers for ICU use, transport and portable electric ventilators, and battery-powered respiratory oxygen monitors. These products are designed to support clinical environments and patient mobility, ensuring precise gas delivery and reliable monitoring.
Where is Bio-Med Devices, Inc. based?
Bio-Med Devices, Inc. is headquartered in the United States. The company’s location in the US aligns with regulatory frameworks governing medical device manufacturing and distribution in North America.
How are Bio-Med Devices, Inc.’s devices classified under FDA regulations?
Bio-Med Devices, Inc.’s products fall under Class II device classification, which typically requires premarket notification (510(k)) clearance before commercial distribution in the US. This classification indicates moderate regulatory oversight due to the devices’ role in critical respiratory support and monitoring.
Which regulatory registries or databases list Bio-Med Devices, Inc.’s devices?
Bio-Med Devices, Inc.’s devices are authorised via FDA 510(k) submissions and UDI (Unique Device Identifier) registrations, ensuring traceability and compliance with US medical device regulations. These registries help track device performance, safety, and regulatory status.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 61 SOUNDVIEW RD, GUILFORD, CT, 06437
- Website
- biomeddevices.com
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- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003952420
- DUNS Number
- —
Catalogue (152)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bio-Med Devices, Inc. | 2003FF2B | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFFP | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFE1 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003U | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFAB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FLEU | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2000KM | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003MB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001FB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002K | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001C | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003KJ | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FF15 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFE1A | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004MB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003KC | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003I | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002M | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFEA | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003K | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFEU | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | TV-100 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002F70A | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004F7015EU | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFG | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FF1 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003GE | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FF1B | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFEUA | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2000K | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003DA | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFH | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003Q | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003TR | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003AJ1 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003H | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | IC-2A | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002F70X | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004F7015X | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FLEUX | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFK | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FL | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002F70D | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (11)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Bio-Med Devices, Inc. has 11 recall records initiated between November 7, 2003, and October 19, 2010, all of which are marked as terminated. The reasons cited include potential failures in a two-way relief valve not activating at low negative pressure levels, adapters becoming occluded, and breathing circuits disconnecting between the adapter and adjacent tubing cuff.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 19, 2010 | Z-0971-2011 | — | terminated | Breathing circuit may disconnect between the adapter adjacent tubing cuff |
| Oct 19, 2010 | Z-0972-2011 | — | terminated | Breathing circuit may disconnect between the adapter adjacent tubing cuff |
| Dec 6, 2004 | Z-0425-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0427-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0428-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0429-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0430-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0424-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0423-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0426-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Nov 7, 2003 | Z-0300-04 | — | terminated | Two way relief valve may fail to activate at the low negative pressure of -3cm H2O. |