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Irrigation Bag
EUDAMEDClass I (EU MDR)
Ref N/AModel 500ml,700ml,800ml, 1000ml,1200ml, 1500ml,1800ml,2000ml,2500ml, 3000ml
Identity
- Device Name
- Irrigation Bag EUDAMED
- Model / Reference
- 500ml,700ml,800ml, 1000ml,1200ml, 1500ml,1800ml,2000ml,2500ml, 3000ml EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975590901027 EUDAMED
- Basic UDI-DI
- 697559090IB001GZ EUDAMED
- EMDN Code
- A100302 ABDOMINAL OSTOMY DRAINAGE / IRRIGATION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Irrigation Bag by Yangzhou Tiansheng Rubber and Plastic Products 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 | 697559090IB001GZ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000016730
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 771c96a5-d230-443f-ac35-ebfb06c06be8 61 fields · synced Oct 6, 2026
- EUDAMED 771c96a5-d230-443f-ac35-ebfb06c06be8-1 61 fields · synced Jun 10, 2026