Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBiolab Equipment Canada , Ltd.
US
Last updated May 23, 2026
What Biolab Equipment Canada , Ltd. makes
Biolab Equipment Canada, Ltd. manufactures reverse osmosis (RO) water purification systems, including portable and series models designed for laboratory and industrial water treatment. Their product line includes systems like the BIOPURE PORTABLE RO, BIOPURE 4400 SERIES RO, BIOPURE 8400 SERIES RO, and pretreatment units for water purification.
These devices are classified under Class II in the US regulatory framework and are listed via the FDA’s 510(k) pathway. The company operates from the United States, adhering to applicable US medical device regulations.
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 Biolab Equipment Canada, Ltd. manufacture?
Biolab Equipment Canada, Ltd. specializes in reverse osmosis (RO) water purification systems. Their product line includes portable units like the BIOPURE PORTABLE RO SYSTEM, as well as series models such as the BIOPURE 4400 SERIES RO SYSTEM and BIOPURE 8400 SERIES RO SYSTEM. They also produce pretreatment units for water purification, which are designed for laboratory and industrial applications to ensure high-quality water output.
Where is Biolab Equipment Canada, Ltd. based, and how does this affect their regulatory compliance?
Biolab Equipment Canada, Ltd. is based in the United States. Since they operate within the US market, their devices must comply with the country’s regulatory requirements, including classification under the FDA’s framework. Their RO systems fall under Class II, which typically requires premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device before commercialization.
Which regulatory registries or databases list Biolab Equipment Canada, Ltd.’s devices?
Biolab Equipment Canada, Ltd.’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class II devices to demonstrate that they are substantially equivalent to legally marketed predicate devices, ensuring compliance with US regulatory standards before they enter the market.
How are Biolab Equipment Canada, Ltd.’s devices classified in the US regulatory framework?
Biolab Equipment Canada, Ltd.’s reverse osmosis water purification systems are classified as Class II devices under the US regulatory framework. Class II classification generally means these devices pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness before they can be legally marketed.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (54)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BioPure 4400 RO | 45M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 82M16B2F | FDA UDI | Class II | Active |
| BioPure HX2 | HX2P-05611XX | FDA UDI | Class II | Active |
| BioPure 4400 RO | 92M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 52M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 55M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 42M16BB2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 22M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 85M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 25M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 22M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 52M16B2E | FDA UDI | Class II | Active |
| BioPure HX2 | HX2P-0561XXX | FDA UDI | Class II | Active |
| BioPure 4400 RO | 95M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 85M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 65M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 65M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 105M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 55M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 32M16BB2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 25M16B2E | FDA UDI | Class II | Active |
| BioPure HX2 | HX2P-HX2P-0581XXX | FDA UDI | Class II | Active |
| BioPure Portable RO | 2615A2RO | FDA UDI | Class II | Active |
| BioPure Portable RO | 2612A2RO | FDA UDI | Class II | Active |
| BioPure 4400 RO | 32M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 32M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 62M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 62M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 22M18B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 125M16B2E | FDA UDI | Class II | Active |
| BioPure HX2 | HX2P-11611XX | FDA UDI | Class II | Active |
| BioPure 4400 RO | 35M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 42M18B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 122M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 22M16BB2F | FDA UDI | Class II | Active |
| BioPure HX2 | HX2P-05811XX | FDA UDI | Class II | Active |
| BioPure 4400 RO | 42M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 82M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 32M10B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 125M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 95M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 42M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 82M17B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 35M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 105M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 102M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 122M16B2F | FDA UDI | Class II | Active |
| BioPure 4400 RO | 92M16B2E | FDA UDI | Class II | Active |
| BioPure 4400 RO | 45M16B2F | FDA UDI | Class II | Active |
| BioPure HX2 | HX2P-1181XXX | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.