Identity
- Trade Name
- ALTECH EUDAMED
- Device Name
- DOUBLE LINE/DOUBLE LUMEN BREATHING CIRCUIT EUDAMED
- Model / Reference
- AL-16039-060.V001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M485AL16039060V0011/ EUDAMED
- Basic UDI-DI
- ++M485BCS0010SH EUDAMED
- Direct Marketing DI
- +M485AL16039060V0011/ EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP 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
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 | ++M485BCS0010SH | 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 72819af4-895e-428b-a7e4-8a1cd93a5a44 61 fields · synced Oct 7, 2026