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S.c.a
EUDAMEDClass I (EU MDR)
Ref 11.054.08Model S.C.A
by Samsun Cerrahi̇ Aletler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
Identity
- Trade Name
- S.C.A EUDAMED
- Device Name
- SEPARATORS EUDAMED
- Model / Reference
- S.C.A EUDAMED11.054.08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680862788784 EUDAMED08698980444956 EUDAMED
- Basic UDI-DI
- 868086255S.C.A3546TS EUDAMED
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER EUDAMEDL149007 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
Category: Hand-held surgical retractor, reusable
S.c.a by Samsun Cerrahi̇ Aletler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 868086255S.C.A3546TS | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000018747
Sources (2)
- EUDAMED 7ec913fc-4241-4397-a6b8-8bb8b111ef4b 61 fields · synced Oct 7, 2026
- EUDAMED a5ccc545-ad51-4124-a61b-92c82f9d5e32 61 fields · synced May 18, 2026