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Aquaflush Sterile Stoma Stopper
EUDAMEDClass IIa (EU MDR)
Ref ACE14/100Ref ACEM12Ref ACEM14Ref ACEM8
Identity
- Trade Name
- Aquaflush Sterile Stoma Stopper EUDAMED
- Device Name
- Sterile Stoma Stopper EUDAMED
- Model / Reference
- ACE14/100 EUDAMEDACEM12 EUDAMEDACEM14 EUDAMEDACEM8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060458870032 EUDAMED05060458870179 EUDAMED05060458870186 EUDAMED05060458870155 EUDAMED
- Basic UDI-DI
- B-05060458870032 EUDAMEDB-05060458870179 EUDAMEDB-05060458870186 EUDAMEDB-05060458870155 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
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Also classified as One-piece intestinal ostomy bag, closed-ended.
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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-05060458870032 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Clinisupplies (Nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000026449
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (4)
- EUDAMED 947d2260-b8e2-4d6a-966d-3bad6e992bec 61 fields · synced Jul 27, 2026
- EUDAMED 9e01a42c-9c95-4993-94b0-0b173c91bc13 61 fields · synced May 18, 2026
- EUDAMED edbfcdbd-14dd-4cee-95dc-c9a8660613c0 61 fields · synced May 18, 2026
- EUDAMED ea1f70bb-0928-40d5-9c84-fe9b982497cf 61 fields · synced May 19, 2026