Identity
- Trade Name
- ALTECH EUDAMED
- Device Name
- HME Bacterial - Viral Filters EUDAMED
- Model / Reference
- AL-08032.V002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M485AL08032V0021T EUDAMED
- Basic UDI-DI
- ++M485FLTNS081HY EUDAMED
- Direct Marketing DI
- +M485AL08032V0021T EUDAMED
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Altech by Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++M485FLTNS081HY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş.
- EUDAMED SRN
- TR-MF-000014943
Sources (1)
- EUDAMED 8b437090-db95-40cf-914f-c97ee3681d56 61 fields · synced Oct 8, 2026