Identity
- Trade Name
- Stomachon EUDAMED
- Device Name
- Irritable Bowel Syndrome EUDAMED
- Model / Reference
- 071428 EUDAMED075600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-071428NM EUDAMEDD-075600P5 EUDAMED
- Basic UDI-DI
- B-071428NM EUDAMEDB-075600P5 EUDAMED
- EMDN Code
- G0401 ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMEDNetherlands 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-071428NM | Class IIa | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (2)
- EUDAMED 94d915ae-1d2b-42ed-b80c-5e8181f64309 61 fields · synced Jul 30, 2026
- EUDAMED b034e455-b859-4ce5-84fe-ae57e6ff4516 61 fields · synced May 18, 2026