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Sterile Stoma Stopper
EUDAMEDClass IIa (EU MDR)
Ref Not ApplicableModel VCSS12FRModel VCSS10FRRef Not applicableModel VCSS14FR
Identity
- Device Name
- Sterile Stoma Stopper EUDAMED
- Model / Reference
- VCSS12FR EUDAMEDNot Applicable EUDAMEDVCSS10FR EUDAMEDVCSS14FR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060463890346 EUDAMED05060463890339 EUDAMED05060463890353 EUDAMED
- Basic UDI-DI
- B-05060463890346 EUDAMEDB-05060463890339 EUDAMEDB-05060463890353 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
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-05060463890346 | 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 (3)
- EUDAMED 5e475cb4-35fd-4197-8afd-9cfc6c5066b0 61 fields · synced Jul 14, 2026
- EUDAMED 6091ac5d-0d9c-4e82-939d-610a801bda34 61 fields · synced May 18, 2026
- EUDAMED e97fc635-5153-49da-8451-03746c64ece7 61 fields · synced May 19, 2026