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Your First Enzymatic & Non-Enzymatic Sponges
EUDAMEDFDA UDIClass I (EU MDR)
Ref 17-155Ref 17-277
Identity
- Trade Name
- Batrik Your First Check Tubular Sponge w/220mL Enz. Sol. FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Your First Enzymatic & Non-Enzymatic Sponges EUDAMEDReady to use Tubular sponge with 220 ml of enzymatic solution FDA UDI
- Model / Reference
- 17-155 EUDAMEDFDA UDI17-277 EUDAMED
- Description
- Ready to use Tubular sponge with 220 ml of enzymatic solution FDA UDI
Identifiers
- Catalog Number
- 17-155 FDA UDI
- Primary DI / UDI-DI
- 00690521015951 EUDAMEDFDA UDI00690521019256 EUDAMED
- 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 (3)
- EUDAMED e826111f-1f85-408c-85d2-2349a3dab096 61 fields · synced Aug 4, 2026
- EUDAMED 37729082-0687-4042-9c4d-c286c795159b 61 fields · synced May 18, 2026
- FDA UDI 40e7fdbe-cf12-4a76-a448-713cdcb0bfa9 35 fields · synced May 30, 2026