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Ostomy Bags and Accessories
EUDAMEDClass I (EU MDR)
Ref MW43aModel MW34a MW34b MW34c （size 40mm,45mm, 50mm,60mm, 70mm, 75mm or Customized Size )
Identity
- Device Name
- Ostomy Bags and Accessories EUDAMED
- Model / Reference
- MW34a MW34b MW34c （size 40mm,45mm, 50mm,60mm, 70mm, 75mm or Customized Size ) EUDAMEDMW43a EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975883470926 EUDAMED
- Basic UDI-DI
- 697588347OstomyBagVM EUDAMED
- EMDN Code
- V0812 FECES AND URINE COLLECTION AIDS (BED PANS AND PARROTS) 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
Ostomy Bags and Accessories by Hospital & Homecare Medical Device Co., Ltd. China — 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 | 697588347OstomyBagVM | Class I | Active |
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Manufacturer
- Manufacturer
- Hospital & Homecare Medical Device Co., Ltd. China
- EUDAMED SRN
- CN-MF-000032014
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED c0a75a34-9076-4154-8ead-32f928ad400c 61 fields · synced Oct 5, 2026