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Sign in to claim this brandTypenex Medical, LLC
United States·US-MF-000024001
Last updated September 17, 2026
What Typenex Medical, LLC makes
Typenex Medical, LLC manufactures tissue embedding moulds, general specimen microscopy slides, microscope slide coverslips, and related in vitro diagnostic devices, all designed for single-use in laboratory settings. The company also produces closed-wound drainage systems, including non-bioabsorbable drains and drainage kits, vascular catheter introduction sets, heat/moisture exchangers with microbial filtration for medical gases, and blood irradiation indicators.
These devices are classified as Class I and Class II medical devices and are listed in the FDA’s Unique Device Identification (FDA UDI) system. The company 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 devices does Typenex Medical, LLC manufacture?
Typenex Medical, LLC manufactures tissue embedding moulds, general specimen microscopy slides, microscope slide coverslips, and related in vitro diagnostic devices designed for single-use in laboratory settings. The company also produces closed-wound drainage systems, including non-bioabsorbable drains and drainage kits, vascular catheter introduction sets, heat/moisture exchangers with microbial filtration for medical gases, and blood irradiation indicators. These products are made for specific clinical and laboratory applications as described in the device data.
Where is Typenex Medical, LLC based?
Typenex Medical, LLC is based in the United States, as explicitly stated in the device data under the COUNTRY field and confirmed in the SUMMARY section. This indicates the company’s primary operational location is within the U.S., though no specific city or state is provided in the source material.
In which regulatory registry are Typenex Medical, LLC’s devices listed?
Typenex Medical, LLC’s devices are listed in the FDA’s Unique Device Identification (FDA UDI) system, as indicated in the LISTED IN field and reiterated in the SUMMARY. This registry is used to track and identify medical devices distributed in the United States, and inclusion here means the devices have been assigned UDIs for traceability, not that the company or its devices are approved or cleared.
How are Typenex Medical, LLC’s devices classified under regulatory frameworks?
Typenex Medical, LLC’s devices are classified as Class I and Class II medical devices, as stated in the DEVICE CLASSES field and confirmed in the SUMMARY. This classification reflects the level of regulatory control required based on risk, with Class I being low risk and Class II requiring special controls. Classification applies to individual devices, not the company as a whole, and does not imply approval or certification.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 300, East Randolph Street, Chicago, United States
- Website
- www.typenex.com
- —
- —
- [email protected]
- Phone
- +1 312 888-4064
- PRRC Contact
- Michael Choquette
- EUDAMED SRN
- US-MF-000024001
- FDA FEI Number
- 3005720829
- DUNS Number
- —
Catalogue (873)
Page 15 of 18| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Microscope Slides | PS0401D | FDA UDI | Class I | Active |
| Embedding Cassette | EC0607TXS | FDA UDI | Class I | Active |
| Cassette Stainless Steel Base Mold | CM0101 | FDA UDI | Class I | Active |
| Embedding Cassette | EC0606YXS | FDA UDI | Class I | Active |
| Embedding Cassette | EC0506HXB | FDA UDI | Class I | Active |
| Rad Control | RT0101XB | FDA UDI | Class I | Active |
| Embedding Cassette | EC0604BXT | FDA UDI | Class I | Active |
| Typenex Wound Drainage | WD0704T | FDA UDI | Class I | Active |
| Typenex Surgical Reusable Optical Fiber | MF200RST205 | FDA UDI | Class II | Unknown |
| Embedding Cassette | EC0404PXB | FDA UDI | Class I | Active |
| Fibernex | LF0101X365 | FDA UDI | Class II | Active |
| Embedding Cassette | EC0204AXS | FDA UDI | Class I | Active |
| Embedding Cassette | EC0606TXS | FDA UDI | Class I | Active |
| Embedding Cassette | EC0203HXT | FDA UDI | Class I | Active |
| Embedding Cassette | EC0605TXS | FDA UDI | Class I | Active |
| Typenex Heat and Moisture Exchanger | RE0201 | FDA UDI | Class II | Active |
| Embedding Cassette | EC0608AXB | FDA UDI | Class I | Active |
| Typenex Wound Drainage | WD0401P | FDA UDI | Class I | Active |
| Embedding Cassette | EC0306NXS | FDA UDI | Class I | Active |
| Embedding Cassette | EC0506WXS | FDA UDI | Class I | Active |
| Typenex Wound Drainage | WD0503TK1 | FDA UDI | Class I | Active |
| Embedding Cassette | EC0306WXS | FDA UDI | Class I | Active |
| Specimen Collection Swab | SW0201 | FDA UDI | Class I | Unknown |
| Microscope Cover Glass | MC0115 | FDA UDI | Class I | Active |
| Typenex Introducer Set | MS1244S | FDA UDI | Class II | Active |
| Embedding Cassette | EC0104PXT | FDA UDI | Class I | Active |
| Tourniquets | TQ0102N | FDA UDI | Class I | Active |
| Embedding Cassette | EC0609PXT | FDA UDI | Class I | Active |
| Medical Face Shield | FS0101 | FDA UDI | Class I | Unknown |
| Specimen Collection Swab | SW0103XSP | FDA UDI | Class I | Unknown |
| Microscope Slides | ES0203W | FDA UDI | Class I | Active |
| Typenex Wound Drainage | WD0401 | FDA UDI | Class I | Active |
| Microscope Slides | ES0202W | FDA UDI | Class I | Active |
| Embedding Cassette | EC0303AXB | FDA UDI | Class I | Active |
| Embedding Cassette | EC0404PXT | FDA UDI | Class I | Active |
| Microscope Cover Glass | MC0102 | FDA UDI | Class I | Active |
| Specimen Collection Swab | SW0203XSP | FDA UDI | Class I | Unknown |
| Embedding Cassette | EC0306NXB | FDA UDI | Class I | Active |
| Embedding Cassette | EC0605BXT | FDA UDI | Class I | Active |
| Specimen Collection Swab | SW0202X80 | FDA UDI | Class I | Unknown |
| Embedding Cassette | EC0602KXB | FDA UDI | Class I | Active |
| Embedding Cassette | EC0203TXBA | FDA UDI | Class I | Active |
| Microscope Slides | PS0401Y | FDA UDI | Class I | Active |
| Embedding Cassette | EC0609AXT | FDA UDI | Class I | Active |
| Embedding Cassette | EC0607BXS | FDA UDI | Class I | Active |
| Embedding Cassette | EC0506GXT | FDA UDI | Class I | Active |
| Fibernex Laser System | LS0201 | FDA UDI | Class II | Active |
| Embedding Cassette | EC0205YXB | FDA UDI | Class I | Active |
| Typenex Wound Drainage | WD0703TK5 | FDA UDI | Class I | Active |
| Visibulb | CEB02 | FDA UDI | Class I | Active |
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