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Wound Drainage System
EUDAMEDClass IIa (EU MDR)
Ref PDS400RPDPTModel Wound Drainage System
Identity
- Device Name
- Wound Drainage System EUDAMED
- Model / Reference
- Wound Drainage System EUDAMEDPDS400RPDPT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970240895268 EUDAMED
- Basic UDI-DI
- 697024089WDSS8 EUDAMED
- Direct Marketing DI
- 06970240895268 EUDAMED
- EMDN Code
- A0601010102 DRAINAGE SYSTEMS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Wound Drainage System by Ningbo Luke Medical Devices Co., LTD — Class IIa — 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 | 697024089WDSS8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Luke Medical Devices Co., LTD
- EUDAMED SRN
- CN-MF-000011732
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ec2fd152-c233-490a-b1fd-c2be2d6ae581 61 fields · synced Oct 8, 2026