Identity
- Trade Name
- Stomachon EUDAMED
- Device Name
- Irritable Bowel Syndrome EUDAMED
- Model / Reference
- 075044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-075044NT EUDAMED
- Basic UDI-DI
- B-075044NT EUDAMED
- EMDN Code
- G0401 ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Croatia 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
Stomachon by PK Benelux BV — Class IIa — 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-075044NT | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (1)
- EUDAMED c519f4f2-a149-41fb-9fb0-990c926170a4 61 fields · synced Jun 19, 2026