Identity
- Trade Name
- ASELTECH EUDAMED
- Device Name
- SEPARATOR EUDAMED
- Model / Reference
- ASELTECH EUDAMEDBK-1110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681376036057 EUDAMED
- Basic UDI-DI
- 8681376ASELTECH201501A9 EUDAMED
- EMDN Code
- L149007 ENT SPOONS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Aseltech by Asel Tibbi Aletler A.S. — Class I — 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 | 8681376ASELTECH201501A9 | Class I | Active |
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Manufacturer
- Manufacturer
- Asel Tibbi Aletler A.S.
- EUDAMED SRN
- TR-MF-000019723
Sources (1)
- EUDAMED 35eaa05c-9133-4f2d-86b4-c955c768e422 61 fields · synced Jun 19, 2026