Identity
- Trade Name
- Proctowash EUDAMED
- Device Name
- Proctowash EUDAMED
- Model / Reference
- PR01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50604857400256 EUDAMED
- Basic UDI-DI
- 506048574PRSL EUDAMED
- EMDN Code
- A03040203 PERINEAL IRRIGATION KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Proctowash by Intermark Medical Innovations Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506048574PRSL | Class I | Active |
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Manufacturer
- Manufacturer
- Intermark Medical Innovations Ltd
- EUDAMED SRN
- GB-MF-000007221
- Authorised Representative
- Intermark Medical (NI) Ltd XI-AR-000007141
Sources (1)
- EUDAMED 30be6023-d53f-429e-af45-c2234ffe74c2 61 fields · synced May 22, 2026