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Sign in to claim this brandDi-Chem, Incorporated
US
Last updated May 27, 2026
What Di-Chem, Incorporated makes
Di-Chem, Incorporated manufactures haemodialysis concentrates, specifically sterile additives designed to be mixed with water for use in haemodialysis treatment. Their primary product is the Di-Chem Hemodialysate Additive, which provides electrolytes and other essential components for dialysis fluid preparation.
The company’s haemodialysis additives are classified as Class II medical devices under US regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use within 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 Di-Chem, Incorporated manufacture?
Di-Chem, Incorporated specializes in haemodialysis concentrates, specifically sterile haemodialysate additives. These products are formulated to be mixed with water to create dialysis fluid, supplying essential electrolytes and components required during haemodialysis treatment. Their primary focus is on supporting renal replacement therapy in clinical settings.
Where is Di-Chem, Incorporated based, and where are their devices intended for use?
Di-Chem, Incorporated is based in the United States. Their haemodialysis concentrates, including the Di-Chem Hemodialysate Additive, are designed for use within the US market, adhering to applicable regulatory standards for medical devices in that region.
How are Di-Chem’s haemodialysis additives classified under US regulations?
Di-Chem’s haemodialysis concentrates, such as the Di-Chem Hemodialysate Additive, are classified as Class II medical devices under the US regulatory framework. This classification applies due to their role in providing critical components for haemodialysis, where moderate risk is associated with their use, requiring special controls to ensure safety and effectiveness.
Are Di-Chem’s devices listed in any regulatory registries?
Yes, Di-Chem’s haemodialysis additives are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices in the US, allowing healthcare providers, regulators, and other stakeholders to identify and verify the devices through their assigned UDI.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dichem-us.com
- —
- —
- [email protected]
- Phone
- 800-847-2598
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 108677253
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Di-Chem Hemodialysate Additive | BAK-12 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-90 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAC-961 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAC-04 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-906 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-903 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-10 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | CA-200 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-13 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-901 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAC-963 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-06 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-907 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-08 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAC-03 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAC-964 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | KAc-200 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-11 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-909 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAC-21 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-908 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAC-962 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAC-965 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-905 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-904 | FDA UDI | Class II | Active |
| Di-Chem Hemodialysate Additive | BAK-902 | FDA UDI | Class II | Active |
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