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Aysam
EUDAMEDClass IIb (EU MDR)
Ref A1982635
by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi
Identity
- Trade Name
- AYSAM EUDAMED
- Device Name
- KILITLI VIDA TITANYUM 5 MM KAFA (LOCKING SCREW TITANIUM 5 MM HEAD) 2,7 X 35 MM EUDAMED
- Model / Reference
- A1982635 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684543833633 EUDAMED
- Basic UDI-DI
- B-08684543833633 EUDAMED
- EMDN Code
- P09120601 CORTICAL SCREWS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic bone screw (non-sliding)
Aysam by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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- PANGEA — Stryker Corp. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08684543833633 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017437
Sources (1)
- EUDAMED b533a47f-8ac5-4ca5-88c2-4fafe62dbd7a 61 fields · synced Jun 18, 2026