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Aysam
EUDAMEDClass IIb (EU MDR)
Ref A400 02 052 0025
by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi
Identity
- Trade Name
- AYSAM EUDAMED
- Device Name
- SERVİKAL GENİŞLEYEN KAFALI KİLİTLİ VİDA TİTANYUM (CERVICAL EXPANSION HEAD LOCKING SCREW TITANIUM) 4,0 X 18 MM EUDAMED
- Model / Reference
- A400 02 052 0025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698823316198 EUDAMED
- Basic UDI-DI
- B-08698823316198 EUDAMED
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS 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: Cervical spine immobilization system, single-use
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 Cervical spine immobilization system, single-use.
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- PCF Rod — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
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-08698823316198 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017437
Sources (1)
- EUDAMED 53769654-1efe-4300-b657-70162348a67e 61 fields · synced Jun 18, 2026