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Your First Enzymatic & Non-Enzymatic Sponges
EUDAMEDClass I (EU MDR)
Ref 17-177
Identity
- Device Name
- Your First Enzymatic & Non-Enzymatic Sponges EUDAMED
- Model / Reference
- 17-177 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00690521019249 EUDAMED
- Basic UDI-DI
- 6905210SPONGE1000YD EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Medical device disinfection agent
Your First Enzymatic & Non-Enzymatic Sponges by Batrik Medical Manufacturing Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6905210SPONGE1000YD | Class I | Active |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 5f7dae7a-8f60-4356-899b-af9f20ed617d 61 fields · synced Jun 20, 2026