Identity
- Trade Name
- Smartlax peräruiske 50x5ml EUDAMED
- Device Name
- Smartlax peräruiske EUDAMEDEnema EUDAMED
- Model / Reference
- 2150308 EUDAMED812334 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06417927103426 EUDAMED06420615710660 EUDAMED
- Basic UDI-DI
- B-06417927103426 EUDAMED642061571350179BT EUDAMED
- EMDN Code
- G99 GASTROINTESTINAL DEVICES - OTHER EUDAMEDG020301 RECTAL TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass 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
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
Smartlax peräruiske 50x5ml by Galena Pharma Oy — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06417927103426 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06417927103426 | Class I | Active |
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Manufacturer
- Manufacturer
- Galena Pharma Oy
- EUDAMED SRN
- FI-MF-000000588
Sources (2)
- EUDAMED 4141d9e4-2764-4313-bc35-a389d28980fa 61 fields · synced Jul 18, 2026
- EUDAMED d6575b11-d879-4038-9cc5-52d9717e2227 61 fields · synced May 18, 2026