Identity
- Trade Name
- FR19 EUDAMED
- Device Name
- FR19 EUDAMED
- Model / Reference
- FRT-EKS01 BL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682169339027 EUDAMED
- Basic UDI-DI
- 868216933902LR EUDAMED
- EMDN Code
- C90010301 HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Fr19 by Fora Grup Savunma Teknoloji̇leri̇ — 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 | 868216933902LR | Class I | Active |
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Manufacturer
- Manufacturer
- Fora Grup Savunma Teknoloji̇leri̇
- EUDAMED SRN
- TR-MF-000034360
Sources (1)
- EUDAMED fe3164a4-9c0c-4861-a13f-c660417c7fc0 61 fields · synced Jul 9, 2026