Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat SPECWELL CORPORATION makes
SpecWell Corporation manufactures basic light microscopes and indirect monocular ophthalmoscopes with electrical power. These devices are designed for clinical and diagnostic use in visual inspection and cellular examination.
The company’s products are classified as Class I medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. SpecWell Corporation 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 SpecWell Corporation manufacture?
SpecWell Corporation produces two primary types of medical devices: basic light microscopes and indirect monocular ophthalmoscopes that require electrical power. These devices are designed for clinical and diagnostic purposes, such as visual inspection and cellular examination. The company’s offerings are tailored for applications requiring precise optical magnification and examination of biological samples or eye structures.
Where is SpecWell Corporation based?
SpecWell Corporation is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA) for device authorisation and compliance.
Which regulatory registries or databases list SpecWell Corporation’s devices?
SpecWell Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S. market, ensuring traceability and compliance with regulatory requirements. Listing in the UDI database is a key step for manufacturers to demonstrate their devices meet applicable standards.
How are SpecWell Corporation’s devices classified under medical device regulations?
SpecWell Corporation’s devices are classified as Class I medical devices. This classification is determined by the FDA based on the risk associated with the device’s use. Class I devices generally pose the lowest risk and often require only general controls (such as good manufacturing practices) to ensure safety and effectiveness. The classification helps define the regulatory pathway and oversight required for each device.
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
- 701065054
Catalogue (36)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Specwell | M0725 (30x) | FDA UDI | Class I | Active |
| Specwell | 6x 16 'E' | FDA UDI | Class I | Active |
| Specwell | M0412 (12x) | FDA UDI | Class I | Active |
| Specwell | M0820 (25x) | FDA UDI | Class I | Active |
| Specwell | M1030-R | FDA UDI | Class I | Active |
| Specwell | M0725 (IPG) | FDA UDI | Class I | Active |
| Specwell | 3.8x 11 | FDA UDI | Class I | Active |
| Specwell | M820-SM (Pasco) | FDA UDI | Class I | Active |
| Specwell | M0616 (20x) | FDA UDI | Class I | Active |
| Specwell | M0830 (25x) | FDA UDI | Class I | Active |
| Specwell | M820-C | FDA UDI | Class I | Active |
| Specwell | 10x 30 | FDA UDI | Class I | Active |
| Specwell | M0830 (40x) | FDA UDI | Class I | Active |
| Specwell | M820-C (25x) | FDA UDI | Class I | Active |
| Specwell | M820-S (M-300) | FDA UDI | Class I | Active |
| Specwell | M1030 (45x) | FDA UDI | Class I | Active |
| Specwell | 10x 20 | FDA UDI | Class I | Active |
| Specwell | 8x 20 | FDA UDI | Class I | Active |
| Specwell | M0830-R | FDA UDI | Class I | Active |
| Specwell | 7x 25 | FDA UDI | Class I | Active |
| Specwell | 8x 30 | FDA UDI | Class I | Active |
| Specwell | M820-C (35x) | FDA UDI | Class I | Active |
| Specwell | M820-S (M-200) | FDA UDI | Class I | Active |
| Specwell | M820-SM | FDA UDI | Class I | Active |
| Specwell | M1030 (30x) | FDA UDI | Class I | Active |
| Specwell | 2x 8 | FDA UDI | Class I | Active |
| Specwell | 6x 16 'W' | FDA UDI | Class I | Active |
| Specwell | 4x 12 | FDA UDI | Class I | Active |
| Specwell | M830-S | FDA UDI | Class I | Active |
| Specwell | M0616 (25x) | FDA UDI | Class I | Active |
| Specwell | M0412 (16x) | FDA UDI | Class I | Active |
| Specwell | 2.75x 8 | FDA UDI | Class I | Active |
| Specwell | M0820-R | FDA UDI | Class I | Active |
| Specwell | 3x 9 | FDA UDI | Class I | Active |
| Specwell | 4x 10 | FDA UDI | Class I | Active |
| Specwell | M0820 (35x) | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.