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Your First Enzymatic & Non-Enzymatic Cleaners
EUDAMEDFDA UDIClass I (EU MDR)
Ref SS-21-3004
Identity
- Trade Name
- Batrik PrAmLi Enzyme Detergent Super Concentrate FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Your First Enzymatic & Non-Enzymatic Cleaners EUDAMEDPrAmLi Enzyme Detergent Super Concentrate, 1 x 3.8 L FDA UDI
- Model / Reference
- SS-21-3004 EUDAMEDFDA UDI
- Description
- PrAmLi Enzyme Detergent Super Concentrate, 1 x 3.8 L FDA UDI
Identifiers
- Catalog Number
- SS-21-3004 FDA UDI
- Primary DI / UDI-DI
- 00690521016705 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
Your First Enzymatic & Non-Enzymatic Cleaners by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 68c39ac2-00fd-45e5-b188-97845a1374ed 61 fields · synced Jul 22, 2026
- FDA UDI 5f13a040-19c2-42ef-84fd-e1b0142edbe8 36 fields · synced May 30, 2026