Altech
by Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. 627 variants
Ref AL-1421.V010
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++M485BCNS0010ZU +M485AL1421V0101N | Date29 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- DOUBLE LINE/DOUBLE LUMEN BREATHING CIRCUIT (Non-Sterile)
- Model / Reference
- AL-1421.V010
- Primary DI / UDI-DI
- +M485AL1421V0101N
- Basic UDI-DI
- ++M485BCNS0010ZU
- Direct Marketing DI
- +M485AL1421V0101N
- EMDN Code
- R02010102 Breathing circuits, with water trap
- Device Class
- Class IIa
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000014943
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No