Identity
- Trade Name
- Dutchmed EUDAMED
- Device Name
- HME Bacterial - Viral Filters EUDAMED
- Model / Reference
- DM-STF-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697645018792 EUDAMED
- Basic UDI-DI
- ++M485FLTNS081HY EUDAMED
- Direct Marketing DI
- 08697645018792 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
Dutchmed 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 99cc6909-ae01-40a6-b5df-6148d1d9ddc0 61 fields · synced Oct 6, 2026