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US
Last updated May 24, 2026
What MAR COR PURIFICATION, INC. makes
MarCor Purification, Inc. manufactures reverse-osmosis water purification systems designed for medical-grade water production, including the BioPure 4400 RO series. The company also produces haemodialysis bicarbonate solution preparation mixers, such as the SDS Bicarb Systems, and microbial water purification filters that are not intended for sterilization, including the 23 G models.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI databases. MarCor Purification, Inc. 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 MarCor Purification, Inc. manufacture?
MarCor Purification, Inc. specializes in three primary categories of medical devices: reverse-osmosis water purification systems (like the BioPure 4400 RO series) for producing high-purity medical-grade water; haemodialysis bicarbonate solution preparation mixers (such as the SDS Bicarb Systems) to ensure precise mixing for dialysis treatments; and microbial water purification filters (e.g., the 23 G models) designed to reduce microbial contamination in non-sterile applications. These devices focus on water safety and purity critical for medical and dialysis environments.
Where is MarCor Purification, Inc. based, and how does that affect its regulatory oversight?
MarCor Purification, Inc. is headquartered in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Since the company’s products are classified as Class II devices, they are subject to FDA’s pre-market notification (510(k)) process and must comply with FDA’s Unique Device Identification (UDI) requirements. The U.S. regulatory framework ensures these devices meet safety and performance standards before entering the market.
Which regulatory registries or databases list MarCor Purification, Inc.’s devices?
MarCor Purification, Inc.’s devices are included in the FDA’s 510(k) database, which tracks pre-market notifications for Class II medical devices to demonstrate substantial equivalence to existing approved products. Additionally, their devices appear in the FDA’s UDI (Unique Device Identification) database, which standardizes identification for traceability, safety monitoring, and regulatory compliance. These listings help healthcare providers and regulators verify device authorization and track post-market performance.
How are MarCor Purification, Inc.’s devices classified under FDA regulations, and why does this matter?
MarCor Purification, Inc.’s devices are classified as Class II under FDA regulations, indicating they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification means the company must submit a 510(k) premarket submission to demonstrate their devices meet FDA requirements, often referencing a predicate device or incorporating performance standards. Class II classification ensures these devices undergo rigorous review to maintain high standards for medical-grade water systems, dialysis mixers, and microbial filters.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- mcpur.com
- —
- —
- [email protected]
- Phone
- 8006333080
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 019056181
Catalogue (194)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 23 G | RO,23G-6K,208/230V,60HZ,50% | FDA UDI | Class II | Active |
| 23 G | RO,23G-6K,460V,60HZ,50% | FDA UDI | Class II | Active |
| SDS Bicarb Systems | SDS,REMOTE,1 ACID,1 BICARB,HD,70G TANK | FDA UDI | Class II | Active |
| BioPure HX2 | HX2P-05811XX | FDA UDI | Class II | Active |
| BioPure 4400 RO | 22M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 52M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 92M16B2E | FDA UDI | Class II | Active |
| SDS Bicarb Systems | SDS,REMOTE,BICARB ONLY,100G TANK | FDA UDI | Class II | Active |
| 23 G | RO,23G-9K,460V,60HZ,75% | FDA UDI | Class II | Active |
| BioPure 4400 RO | 122M16B2E | FDA UDI | Class II | Active |
| 23 G | RO,23G-10.5K,380V,50HZ,75% | FDA UDI | Class II | Active |
| 23 G | RO,23G-7.5K,460V,60HZ,75% | FDA UDI | Class II | Active |
| 23 G | RO,23G-13.5K,208/230V,60HZ,50% | FDA UDI | Class II | Active |
| BioPure 4400 RO | 82M17B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 42M16B2F | FDA UDI | Class II | Active |
| 23 G | RO,23G-16.5K,460V,60HZ,75% | FDA UDI | Class II | Active |
| 700 Series | RO,S702,TF,50H,SH,WH | FDA UDI | Class II | Active |
| 23 G | RO,23G-7.5K,208/230V,60HZ,50%,1PH | FDA UDI | Class II | Active |
| MCB Series | MCB 202-50 BICARB SNGL SYS | FDA UDI | Class II | Active |
| 23 G | RO,23G-10.5K,208/230V,60HZ,75%,1PH | FDA UDI | Class II | Active |
| MCB Series | BICARB SYSTEM,MCB212-100,LG DIST PUMP | FDA UDI | Class II | Active |
| MCB Series | BICARD SYSTEM, MCB212-100, LG 220V/50HZ | FDA UDI | Class II | Active |
| MCB Series | MCB 212-100 BICARB SEMI SYS | FDA UDI | Class II | Active |
| BioPure 4400 RO | 42M16BB2E | FDA UDI | Class II | Active |
| SDS Bicarb Systems | SDS,REMOTE,1 ACID,1 BICARB,70G TANK | FDA UDI | Class II | Active |
| 23 G | RO,23G-15K,208/230V,60HZ,50% | FDA UDI | Class II | Active |
| 23 G | RO,23G-10.5K,460V,60HZ,75% | FDA UDI | Class II | Active |
| Millenium HX | RO,MILLENIUM HX,750GPD,115~,60HZ | FDA UDI | Class II | Active |
| BioPure 4400 RO | 25M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 105M16B2E | FDA UDI | Class II | Active |
| Cwp | RO,CWP,20LPM,102S | FDA UDI | Class II | Active |
| 23 G | RO,23G-15K,380V,50HZ,50% | FDA UDI | Class II | Active |
| 23 G | RO,23G-4.5K,208/230V,60HZ,50%,1PH | FDA UDI | Class II | Active |
| Posiclear | FILTER, POSICLEAR, 20" 222, FLAT | FDA UDI | Class II | Active |
| 23 G | RO,23G-6K,380V,50HZ,50% | FDA UDI | Class II | Active |
| 23 G | RO,23G-15K,208/230V,60HZ,75% | FDA UDI | Class II | Active |
| 700 Series | RO,S704,TF,60H,TL,WH,COLD | FDA UDI | Class II | Active |
| Eon | RO,EON,115~,50/60HZ | FDA UDI | Class II | Active |
| PSDS Bicarb Systems | PSDS,2 ACID,1 BICARB,HD | FDA UDI | Class II | Active |
| Eon | RO,EON,115~,50/60HZ | FDA UDI | Class II | Active |
| BioPure 4400 RO | 32M16BB2E | FDA UDI | Class II | Active |
| 23 G | RO,23G-7.5K,208/230V,60HZ,75% | FDA UDI | Class II | Active |
| 700 Series | RO,S701,TF,50H,SH,WH | FDA UDI | Class II | Active |
| BioPure 4400 RO | 125M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 85M16B2F | FDA UDI | Class II | Active |
| PSDS Bicarb Systems | PSDS,2 ACID,1 BICARB | FDA UDI | Class II | Active |
| BioPure 4400 RO | 32M16B2F | FDA UDI | Class II | Active |
| 23 G | RO,23G-4.5K,208/230V,60HZ,50% | FDA UDI | Class II | Active |
| 23 G | RO,23G-9K,208/230V,60HZ,50% | FDA UDI | Class II | Active |
| 23 G | RO,23G-7.5K,460V,60HZ,50% | FDA UDI | Class II | Active |
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Mar Cor Purification, Inc. has three FDA recall records initiated between June 27, 2012, and April 24, 2014, all of which are marked as terminated. The recalls involve potential issues with crimp connections in pump head assemblies, high inlet water pressure exceeding specifications, and a specific lot of water inlet solenoid valves in their Central Water Plant (CWP) reverse osmosis systems (models 102, 104, and 106). The reasons cited include potential resistive heating, delayed treatment, and the possibility of solenoid valve failure.
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 |
|---|---|---|---|---|
| Apr 24, 2014 | Z-1563-2014 | — | terminated | Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. The potential exists that the water inlet solenoid valve could cease to function. If this occurs, CWP will stop producing reverse osmosis water. |
| Jun 26, 2013 | Z-1213-2014 | — | terminated | High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment. |
| Jun 27, 2012 | Z-1201-2014 | — | terminated | There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit. |