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Elite Water
EUDAMEDClass IIa (EU MDR)
Ref EW-650Model ELITE WATER Sterile Inhalation Water Filled Into the 650mL Bottle Closed With Heat
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- ELITE WATER EUDAMED
- Device Name
- ELITE WATER Sterile Inhalation Water Filled Into the 650mL Bottle Closed With Heat EUDAMED
- Model / Reference
- ELITE WATER Sterile Inhalation Water Filled Into the 650mL Bottle Closed With Heat EUDAMEDEW-650 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18699415725388 EUDAMED
- Basic UDI-DI
- B-18699415725388 EUDAMED
- EMDN Code
- R060203 INHALATION THERAPY HUMIDIFICATION LIQUIDS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Elite Water by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18699415725388 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 01b3e4f9-ad35-4e0f-b0c5-4e6f301a2e55 61 fields · synced Oct 6, 2026