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NPWT Sponge
EUDAMEDClass IIb (EU MDR)
Ref YHM-PVA-05Model 5cm×5cm×1cm-PVA, 7.5cm×5cm×1cm-PVA, 10cm×5cm×1cm-PVA, 15cm×5cm×1cm-PVA, 15cm×10cm×1cm-PVA, 15cm×15cm×1cm-PVA, 20cm×10cm×1cm-PVA, 20cm×15cm×1cm-PVA, 20cm×20cm×1cm-PVA, 20cm×30cm×1cm-PVA
Identity
- Device Name
- NPWT Sponge EUDAMED
- Model / Reference
- 5cm×5cm×1cm-PVA, 7.5cm×5cm×1cm-PVA, 10cm×5cm×1cm-PVA, 15cm×5cm×1cm-PVA, 15cm×10cm×1cm-PVA, 15cm×15cm×1cm-PVA, 20cm×10cm×1cm-PVA, 20cm×15cm×1cm-PVA, 20cm×20cm×1cm-PVA, 20cm×30cm×1cm-PVA EUDAMEDYHM-PVA-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948534706507 EUDAMED
- Basic UDI-DI
- 69485347NPWTS2AC030102K9 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
NPWT Sponge by Shandong Wego New Life Medical Devices Co., Ltd. — Class IIb — 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 | 69485347NPWTS2AC030102K9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shandong Wego New Life Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000015950
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED d2dcebd9-9b52-4cc8-847f-fb64f4d88664 61 fields · synced Oct 8, 2026