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Your First Enzymatic & Non-Enzymatic Sponges
EUDAMEDFDA UDIClass I (EU MDR)
Ref 17-122
Identity
- Trade Name
- Batrik Your First PrAmLi Power Enzyme FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Your First Enzymatic & Non-Enzymatic Sponges EUDAMEDBedside Enzymatic Sponge Kits, Dry Tubular Sponge in a large freestanding pouch to use as a basin and simply add 500mL of water FDA UDI
- Model / Reference
- 17-122 EUDAMEDFDA UDI
- Description
- Bedside Enzymatic Sponge Kits, Dry Tubular Sponge in a large freestanding pouch to use as a basin and simply add 500mL of water FDA UDI
Identifiers
- Catalog Number
- 17-122 FDA UDI
- Primary DI / UDI-DI
- 00690521015074 EUDAMED00690521015005 FDA UDI
- Basic UDI-DI
- 6905210SPONGE1000YD 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
- France 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical device disinfection agent
Your First Enzymatic & Non-Enzymatic Sponges by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Medical device disinfection agent.
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- Enzym Med Wipes — Laboratorium Dr. Deppe GmbH · Class I
- Sterilbios — AMIL CARE CORPORATION · Class I
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 | 6905210SPONGE1000YD | 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 824f217d-5352-42d1-a49a-b588b533d6d1 61 fields · synced Jun 18, 2026
- FDA UDI c4a28aac-925a-4829-8275-7c277063893d 36 fields · synced May 30, 2026