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X1c1n356413-10-Ca2
EUDAMEDClass I (EU MDR)
Ref X1C1N356413-10-CA2Model Aurum Plus
Identity
- Model / Reference
- Aurum Plus EUDAMEDX1C1N356413-10-CA2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05024310003105 EUDAMED
- Basic UDI-DI
- 5024310X1MZ EUDAMED
- EMDN Code
- A100199 DEVICES FOR ABDOMINAL OSTOMY - ONE PIECE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: One-piece intestinal ostomy bag, closed-ended
X1c1n356413-10-Ca2 by Welland Medical Ltd — Class I — MDR — 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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- SenSura Mio Convex — Coloplast A/S · Class I
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 | 5024310X1MZ | Class I | Active |
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Manufacturer
- Manufacturer
- Welland Medical Ltd
- EUDAMED SRN
- GB-MF-000033194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED b73515b0-0731-4f6b-922a-635ee71ca351 61 fields · synced Aug 1, 2026