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Your First Enzymatic & Non-Enzymatic Cleaners
EUDAMEDFDA UDIClass I (EU MDR)
Ref SS-21-4012
Identity
- Trade Name
- Batrik PrAmLi Power Enzyme FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Your First Enzymatic & Non-Enzymatic Cleaners EUDAMED"PrAmLi Power3 Enzymes, Ready to Use Foaming Spray, 12 x 946 mL (12 x 32 oz)" FDA UDI
- Model / Reference
- SS-21-4012 EUDAMEDFDA UDI
- Description
- "PrAmLi Power3 Enzymes, Ready to Use Foaming Spray, 12 x 946 mL (12 x 32 oz)" FDA UDI
Identifiers
- Catalog Number
- SS-21-4012 FDA UDI
- Primary DI / UDI-DI
- 00690521015869 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210SOLUTION10002Z EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
- GMDN Term
- Medical device disinfection agent FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Austria 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
Category: Medical device disinfection agent
Your First Enzymatic & Non-Enzymatic Cleaners by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 6905210SOLUTION10002Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 081474aa-a632-451f-8f05-4ae56cb37cbe 61 fields · synced Jul 30, 2026
- FDA UDI 058c679b-26be-44e9-97b9-df4cbf3fa76c 36 fields · synced May 30, 2026