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Your First Enzymatic & Non-Enzymatic Sponges
EUDAMEDFDA UDIClass I (EU MDR)
Ref 717-122
Identity
- Trade Name
- Batrik Cyl. Sponge w/ stand Pouch w/non-Enzymatic FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Your First Enzymatic & Non-Enzymatic Sponges EUDAMEDNon-Enzymatic Detergent beside Dry Tubular Sponge Kit FDA UDI
- Model / Reference
- 717-122 EUDAMEDFDA UDI
- Description
- Non-Enzymatic Detergent beside Dry Tubular Sponge Kit FDA UDI
Identifiers
- Catalog Number
- 717-122 FDA UDI
- Primary DI / UDI-DI
- 00690521018266 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
Your First Enzymatic & Non-Enzymatic Sponges 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 | 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 88778554-00f4-4cc1-9be2-23d1a330c0a1 61 fields · synced Aug 3, 2026
- FDA UDI 3c36091e-1558-4e4e-aba6-58b07d6ecc55 36 fields · synced May 30, 2026