Identity
- Trade Name
- MADA MEDICAL PRODUCTS FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- A substance containing a chemical agent(s) intended to destroy harmful microorganisms or inhibit their activity on a medical device (e.g., surgical or dental instrument); it may also contain surfactants/cleaning agents or biological enzymes (e.g. protease, lipase, amylase). The medical device is intended to be exposed to the substance for a specified period of time to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit; it is not supplied as an aerosol and does not include a wipe. FDA UDI
- Model / Reference
- 7025 FDA UDI
- Description
- A substance containing a chemical agent(s) intended to destroy harmful microorganisms or inhibit their activity on a medical device (e.g., surgical or dental instrument); it may also contain surfactants/cleaning agents or biological enzymes (e.g. protease, lipase, amylase). The medical device is intended to be exposed to the substance for a specified period of time to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit; it is not supplied as an aerosol and does not include a wipe. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815160020733 FDA UDI
- FDA Product Code
- LRJ FDA UDI
- GMDN Term
- Medical device disinfection agent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Medical device disinfection agent
Mada Medical Products by Mada Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Coltene Biosonic UC40 — Topdental (Products) Ltd · Class I
- Enzymatic Detergent — QUADRALENE LTD · Class I
- Enzym Med Wipes — Laboratorium Dr. Deppe GmbH · 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 |
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Manufacturer
- Manufacturer
- Mada Medical Products, Inc.
Sources (1)
- FDA UDI 94c4adac-a543-4b74-946b-3f1eb25f0160 34 fields · synced Jun 8, 2026