Identity
- Trade Name
- STERILE WATER FOR IRRIG (PLASTIC BOTTLE) EUDAMED
- Device Name
- STERILE WATER FOR IRRIGATION EUDAMED
- Model / Reference
- KKF7113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05413760194332 EUDAMED
- Basic UDI-DI
- 0085412GMN000000000004575 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
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: Device sterilization/disinfection container, reusable
Sterile Water For Irrig (plastic Bottle) by Baxter Healthcare SA — Class IIb — 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 | 0085412GMN000000000004575 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Baxter Healthcare SA
- EUDAMED SRN
- CH-MF-000026124
- Authorised Representative
- Baxter Deutschland GmbH DE-AR-000010308
Sources (1)
- EUDAMED 03d0c85f-c8a7-4997-b4a9-8c2f4a21cf19 61 fields · synced Jun 19, 2026