Identity
- Trade Name
- FIXOBANDAGE EUDAMED
- Device Name
- Premium Elastic Bandage EUDAMED
- Model / Reference
- FXB004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684000857059 EUDAMED
- Basic UDI-DI
- 86834009FB7899E8 EUDAMED
- EMDN Code
- M03040199 ELASTIC COMPRESSION BANDAGES - OTHER 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
Fixobandage by Entpromed Sağlik Ürünleri̇ San. Ve Ti̇c. A.ş. — 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 | 86834009FB7899E8 | Class I | Active |
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Manufacturer
- Manufacturer
- Entpromed Sağlik Ürünleri̇ San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000022407
Sources (1)
- EUDAMED d9f52e83-5319-4efe-865c-c3ff3e8660b6 61 fields · synced Oct 6, 2026