Identity
- Trade Name
- YA Makrogoli 10x13,7g EUDAMED
- Device Name
- YA Makrogoli EUDAMED
- Model / Reference
- 9911997 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06418879100730 EUDAMED
- Basic UDI-DI
- B-06418879100730 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 10x13, 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-06418879100730 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Galena Pharma Oy
- EUDAMED SRN
- FI-MF-000000588
Sources (1)
- EUDAMED 009464d2-85be-4546-bc2d-6a01ecc4094c 61 fields · synced Jun 19, 2026