Identity
- Trade Name
- Freka® GastroTube FR 15, ENFit EUDAMED
- Device Name
- Percutaneous Tubes Replacement Sets and Accessories EUDAMED
- Model / Reference
- 7755648 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250273726053 EUDAMED
- Basic UDI-DI
- 42502737NEN60212b000000GQ EUDAMED
- EMDN Code
- G020299 GASTROINTESTINAL FEEDING/ASPIRATION TUBES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Freka® GastroTube FR 15, ENFit by Fresenius Kabi AG — Class IIb — 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 | 42502737NEN60212b000000GQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fresenius Kabi AG
- EUDAMED SRN
- DE-MF-000009273
Sources (1)
- EUDAMED 639da264-eb54-4d8a-b244-77955bcbc098 61 fields · synced Jun 19, 2026