Identity
- Trade Name
- SPECWELL FDA UDI
- Generic Name
- Basic light microscope FDA UDI
- Model / Reference
- M820-S (M-200) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04582697820179 FDA UDI
- FDA Product Code
- HKB FDA UDI
- GMDN Term
- Basic light microscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Basic light microscope
Specwell by Specwell Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic light microscope.
- LW Scientific, Inc. — LW SCIENTIFIC, INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- LW Scientific, Inc. — LW SCIENTIFIC, INC. · Class I
- SEILER MEDICAL DIVISION — SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED · Class I
- LW Scientific, Inc. — LW SCIENTIFIC, INC. · Class I
- LW Scientific, Inc. — LW SCIENTIFIC, INC. · Class I
- ZEISS Axioscope — Carl Zeiss Suzhou Co., Ltd. · Class I
- LW Scientific, Inc. — LW SCIENTIFIC, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Specwell Corporation
Sources (1)
- FDA UDI 5d0b2095-38ef-4e4d-bbae-9b5fea759cfc 32 fields · synced Jun 8, 2026