Is this your brand? Sign in to claim ownership.
Sign in to claim this brandLAKE REGION MEDICAL LIMITED
US
Last updated September 17, 2026
What LAKE REGION MEDICAL LIMITED makes
Lake Region Medical Limited manufactures peripheral vascular guidewires, gastro-urological guidewires, cardiac/peripheral vascular guidewires, general-purpose non-vascular guidewires, and endomyocardial biopsy forceps. Examples of their devices include the THRUWAY™, Starter™ Guidewire, Forté™, M-Wire, ZIPwire™, Triumph, and NuMED, Inc. Bonhoeffer.
The company's devices are classified as Class I and Class II and are listed in the FDA UDI registry. Lake Region Medical Limited 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 Lake Region Medical Limited manufacture?
Lake Region Medical Limited produces a range of guidewires and biopsy tools, specifically peripheral vascular guidewires (manual), gastro‑urological guidewires (single‑use), cardiac/peripheral vascular guidewires (single‑use), general‑purpose non‑vascular guidewires, and single‑use endomyocardial biopsy forceps. This list is taken directly from the provided device categories.
Where is Lake Region Medical Limited headquartered?
The company is based in the United States, as indicated by the COUNTRY field in the supplied data. No other location information is provided, so the answer is limited to the United States.
Which regulatory registry lists the devices from Lake Region Medical Limited?
Lake Region Medical Limited’s devices appear in the FDA UDI (Unique Device Identifier) registry. The LISTED IN field explicitly names "fda_udi," confirming that the FDA’s database is the registry where their device identifiers are recorded.
How are Lake Region Medical Limited’s devices classified under FDA regulations?
The devices are classified as Class I and Class II. The DEVICE CLASSES entry lists both categories, indicating that some of their products fall under the lower‑risk Class I classification while others are considered moderate‑risk Class II, each requiring the appropriate regulatory controls.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 13024 NORTH MAIN ST., TRENTON, GA, 30752
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- 888-272-1001
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3004063494
- DUNS Number
- 988555595
Catalogue (112)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ZIPwire™ | M006630215B0 | FDA UDI | Class I | Active |
| Starter™ Guidewire | M001491371 | FDA UDI | Class II | Active |
| Starter™ Guidewire | M001492261 | FDA UDI | Class II | Active |
| ZIPwire™ | M00146165B0 | FDA UDI | Class II | Active |
| Starter™ Guidewire | M001492251 | FDA UDI | Class II | Active |
| NaviPro™ | M00556220 | FDA UDI | Class II | Active |
| Safari™ | H74939271L0 | FDA UDI | Class II | Active |
| SAFARI2™ Extra Support | H74939597ESXS1 | FDA UDI | Class II | Active |
| Starter™ Guidewire | M001492201 | FDA UDI | Class II | Active |
| Starter™ Guidewire | M001491161 | FDA UDI | Class II | Active |
| Jetstream™ Jetwire | 011525-000 | FDA UDI | Class II | Active |
| ZIPwire™ | M00146151B0 | 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.