Identity
- Trade Name
- Medizyme FDA UDI
- Generic Name
- Medical device cleaning agent FDA UDI
- Device Name
- Enzymatic Detergent for reprocessing medical devices. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Enzymatic Detergent for reprocessing medical devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09335006007410 FDA UDI
- FDA Product Code
- FLG FDA UDI
- GMDN Term
- Medical device cleaning agent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6150 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical device cleaning agent
Medizyme by Whiteley Corporation Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical device cleaning agent.
- ET Foam — Germiphene Corp. · Class I
- Prolystica — STERIS CORPORATION · Class I
- ENDOZIME XP (10 Liter TB63) — Ruhof Corporation · Class I
- Xen Neutral+ 5G — QUADRALENE LIMITED · Class I
- LIQUIZIME (BLUE) (5GL/20L RP) — Ruhof Corporation · Class I
- Skytron Cart Rinse and Drying Agent — Skytron, LLC · Class II
- LIQUIZIME (55 Gallon/220 Liter Drum) — Ruhof Corporation · Class I
- Xen Universal+ 5L — QUADRALENE LIMITED · 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
- Whiteley Corporation Pty Ltd
Sources (1)
- FDA UDI 94212d8b-b3ab-49f0-97fd-6a4c57d2f528 34 fields · synced Jun 8, 2026