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Hu-Friedy
EUDAMEDFDA UDIClass I (EU MDR)
Ref IMS-1222Model Enzymatic Detergents
Identity
- Trade Name
- Hu-Friedy EUDAMEDEnzymax Liquid FDA UDI
- Generic Name
- Medical device cleaning agent FDA UDI
- Device Name
- Enzymax Liquid Concentrated Ultrasonic Detergent and Presoak FDA UDI
- Model / Reference
- Enzymatic Detergents EUDAMEDIMS-1222 EUDAMEDFDA UDI
- Description
- Enzymax Liquid Concentrated Ultrasonic Detergent and Presoak FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10889950036300 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889950CleanersSY EUDAMED
- FDA Product Code
- FLG FDA UDI
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
- GMDN Term
- Medical device cleaning agent FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6150 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical device disinfection agent
Hu-Friedy by Hu-Friedy Manufacturing Co., LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0889950CleanersSY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hu-Friedy Manufacturing Co., LLC
- EUDAMED SRN
- US-MF-000017104
- Authorised Representative
- Hu-Friedy Europe LLC & Co. KG DE-AR-000005530
Sources (2)
- EUDAMED e2c195c5-a5ac-49c6-b8da-7cb0cd17f15e 61 fields · synced Jun 18, 2026
- FDA UDI 7569b9e0-d884-4f16-8750-aa8f100b3e74 34 fields · synced May 25, 2026