Identity
- Trade Name
- Citrizyme, 50 Packet Bag EUDAMEDCitrizyme Ultra Concentrated Enzyme Powder 50 Pouches FDA UDI
- Generic Name
- Medical device cleaning agent FDA UDI
- Device Name
- Citrizyme EUDAMEDUltra Concentrated Enzymatic Evacuation Cleaner and Instrument Pre-Soak 50 Packets FDA UDI
- Model / Reference
- 15260 EUDAMEDFDA UDI
- Description
- Ultra Concentrated Enzymatic Evacuation Cleaner and Instrument Pre-Soak 50 Packets FDA UDI
Identifiers
- Catalog Number
- 15260 FDA UDI
- Primary DI / UDI-DI
- 00310866000022 EUDAMEDFDA UDI
- Basic UDI-DI
- 03108664001GC EUDAMED
- FDA Product Code
- MDZ FDA UDI
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
- GMDN Term
- Medical device cleaning agent FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6992 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 4.2 Gram FDA UDI
Category: Medical device disinfection agent
Citrizyme, 50 Packet Bag by Pascal Company, Inc. — 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 | 03108664001GC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pascal Company Inc.
- EUDAMED SRN
- US-MF-000032036
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 171cfb86-b504-4984-acf1-1c1669612206 61 fields · synced Jul 21, 2026
- FDA UDI 0f5b9ced-e3a9-451e-b4d9-4134789f5ad7 37 fields · synced May 30, 2026