Identity
- Trade Name
- YA Makrogoli 50x13,7g EUDAMED
- Device Name
- YA Makrogoli EUDAMED
- Model / Reference
- 9916501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06418879107302 EUDAMED
- Basic UDI-DI
- B-06418879107302 EUDAMED
- EMDN Code
- G0401 ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
YA Makrogoli 50x13, 7g by Galena Pharma Oy — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06418879107302 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Galena Pharma Oy
- EUDAMED SRN
- FI-MF-000000588
Sources (1)
- EUDAMED 817d23d3-aefb-4402-9e30-5c5dd871fe50 61 fields · synced Jul 29, 2026