FDA Registration
Active
🇺🇸 United States
Cambridge Sensors USA, LLC.
Reg #: 3008700497
·
FEI: 3008700497
·
Expires 2026
Products
10
Proprietary Names
37
Establishment Types
2
Classifications
10
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Registration Details
- Registration Name
- Cambridge Sensors USA, LLC.
- Registration Number
- 3008700497
- FEI Number
- 3008700497
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 23866 W Industrial Dr N
- City
- Plainfield
- State
- IL
- ZIP
- 60585
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222376
Owner / Operator
- Firm Name
- Cambridge Sensors USA, LLC.
- Operator Number
- 10042320
- Address
- 23866 W Industrial Drive N
- City
- Plainfield
- State
- IL
- Postal Code
- 60585
- Country
- US
- Correspondent
- Chris W Sullivan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2022-12-06 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-01-10 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-01-10 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-01-10 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-01-10 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-01-09 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2026-01-15 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2012-11-14 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2012-11-14 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2012-11-14 |
Proprietary Names
microdot 28g Lancet
microdot 26g Lancet
microdot 23g 100ct Lancet
microdot 21g Lancet
microdot 30g Lancet
microdot 23g 200ct Lancet
Nitrile Powder Free Glove (X-Large)
Black Nitrile Powder Free Glove (XX-Large)
Black Nitrile Powder Free Glove (Small)
Black Nitrile Powder Free Glove (X-Large)
Black Nitrile Powder Free Glove (Medium)
Nitrile Powder Free Glove (Small)
Nitrile Powder Free Glove (Medium)
Nitrile Powder Free Glove (XX-Large)
Black Nitrile Powder Free Glove (Large)
Nitrile Powder Free Glove (Large)
microdot
microdot Pro Nitrile Gloves XX-Large
microdot Pro Nitrile Gloves Medium
microdot Pro Nitrile Gloves Small
microdot Pro Nitrile Gloves X-Large
microdot Pro Nitrile Gloves Large
microdot® Pulse Oximeter
Nitrile Examination Gloves - small
Nitrile Examination gloves - medium
Nitrile Examination gloves - Large
Nitrile Examination gloves - small
microdot® Flex Nitrile Gloves Medium
microdot® Flex Nitrile Gloves X-Large
microdot® Flex Nitrile Gloves Small
microdot® Flex Nitrile Gloves Large
microdot Pro
microdot Xtra
microdot® Flex Black Nitrile Gloves X-Large
microdot® Flex Black Nitrile Gloves Large
microdot® Flex Black Nitrile Gloves Small
microdot® Flex Black Nitrile Gloves Medium
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198