Identity
- Trade Name
- Smartlax peräruiske 4x5ml EUDAMED
- Device Name
- Smartlax peräruiske EUDAMEDEnema EUDAMED
- Model / Reference
- 2150001 EUDAMED812332 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06417927103389 EUDAMED06420615710653 EUDAMED
- Basic UDI-DI
- B-06417927103389 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 4x5ml 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-06417927103389 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06417927103389 | Class I | Active |
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Manufacturer
- Manufacturer
- Galena Pharma Oy
- EUDAMED SRN
- FI-MF-000000588
Sources (2)
- EUDAMED 54fecec3-44cc-4da5-b3b8-d4127286a935 61 fields · synced Sep 17, 2026
- EUDAMED aafd554c-9302-4b0a-a25c-665a7c098f9a 61 fields · synced May 19, 2026