Identity
- Trade Name
- Aquaflush Sterile Stoma Stopper EUDAMED
- Device Name
- Sterile Stoma Stopper EUDAMED
- Model / Reference
- ACE10/100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060458870018 EUDAMED
- Basic UDI-DI
- B-05060458870018 EUDAMED
- EMDN Code
- A100199 DEVICES FOR ABDOMINAL OSTOMY - ONE PIECE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: One-piece intestinal ostomy bag, closed-ended
Aquaflush Sterile Stoma Stopper by Clinisupplies (Nanjing) Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as One-piece intestinal ostomy bag, closed-ended.
- SenSura Mio Concave — Coloplast A/S · Class I
- SenSura Mio Convex — Coloplast A/S · Class I
- Hollister — Hollister Incorporated · Class I
- SenSura Mio Convex — Coloplast A/S · Class I
- SenSura Mio Concave — Coloplast A/S · Class I
- Hollister — Hollister Incorporated · Class I
- SenSura Mio — Coloplast A/S · Class I
- SenSura Mio Convex — Coloplast A/S · Class I
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-05060458870018 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clinisupplies (Nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000026449
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED f345aeb8-019a-473e-a0eb-70d40b07f9c5 61 fields · synced Jun 19, 2026