Identity
- Trade Name
- ASELTECH EUDAMED
- Device Name
- REAMER EUDAMED
- Model / Reference
- ASELTECH EUDAMEDBN-9810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681376066078 EUDAMED
- Basic UDI-DI
- 8681376ASELTECH201526AR EUDAMED
- EMDN Code
- L0903 ORTHOPAEDIC SURGERY HAMMERS, 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 | 8681376ASELTECH201526AR | Class I | Active |
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Manufacturer
- Manufacturer
- Asel Tibbi Aletler A.S.
- EUDAMED SRN
- TR-MF-000019723
Sources (1)
- EUDAMED 4aacf5dc-9a4b-4661-8391-37bdefef90e1 61 fields · synced Jun 19, 2026