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Your First Enzymatic & Non-Enzymatic Sponges
EUDAMEDFDA UDIClass I (EU MDR)
Ref 17-111
Identity
- Trade Name
- Batrik Your First Check Cylindrical Sponge w/Enz. Sol FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Your First Enzymatic & Non-Enzymatic Sponges EUDAMEDDry Tubular Sponge with enzymatic solution EcoZyme First Touch FDA UDI
- Model / Reference
- 17-111 EUDAMEDFDA UDI
- Description
- Dry Tubular Sponge with enzymatic solution EcoZyme First Touch FDA UDI
Identifiers
- Catalog Number
- 17-111, 19560-TS-BAG FDA UDI
- Primary DI / UDI-DI
- 00690521014855 EUDAMEDFDA 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
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 Sponges 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 | 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 ccfb2fe7-4e8d-4aa6-90d1-7fd43e2390a1 61 fields · synced Jul 25, 2026
- FDA UDI dc1e127e-0883-48ec-a915-f47f41cc57e9 36 fields · synced May 30, 2026