Identity
- Trade Name
- MDF® FDA UDI
- Generic Name
- Hand-held examination/treatment light FDA UDI
- Device Name
- LUMiNiX® Professional Diagnostic Penlight, MDFBO FDA UDI
- Model / Reference
- MDF621BO FDA UDI
- Description
- LUMiNiX® Professional Diagnostic Penlight, MDFBO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06940211615263 FDA UDI
- FDA Product Code
- KYT FDA UDI
- GMDN Term
- Hand-held examination/treatment light FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
Yes
FDA UDI
Category: Hand-held examination/treatment light
Mdf® by MDF Instruments Medifriend Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held examination/treatment light.
- BV Medical — Medical, Inc. · Class I
- Pack of 6 pcs.ri-pen® — Rudolf Riester GmbH & Co. KG · Class I
- BV Medical — Medical, Inc. · Class I
- KaWe — Medical, Inc. · Class I
- BV Medical — Medical, Inc. · Class I
- BV Medical — Medical, Inc. · Class I
- BV Medical — Medical, Inc. · Class I
- BV Medical — Medical, 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
- MDF Instruments Medifriend Inc.
Sources (1)
- FDA UDI ade93336-cc81-41fc-a3b0-6f9164362fae 33 fields · synced May 30, 2026