Identity
- Trade Name
- Aquaflush® 500X Standard Starter Set EUDAMED
- Device Name
- Aquaflush Transanal Irrigation System EUDAMED
- Model / Reference
- SPAF5X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060458870933 EUDAMED
- Basic UDI-DI
- 5060463890247VC11FSL EUDAMED
- EMDN Code
- G99 GASTROINTESTINAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- 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
Aquaflush® 500X Standard Starter Set by Clinisupplies (Nanjing) Co., 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 | 5060463890247VC11FSL | Class I | Active |
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Manufacturer
- Manufacturer
- Clinisupplies (Nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000026449
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 9c2e88b8-1931-4e21-9854-977e938dfe8a 61 fields · synced Jul 8, 2026