Identity
- Trade Name
- DRAINAGE CATHETER & SETS EUDAMED
- Device Name
- DRAINAGE CATHETER & SETS EUDAMED
- Model / Reference
- PDS-P8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00812261012094 EUDAMED
- Basic UDI-DI
- 081226101DCS007LH EUDAMED
- EMDN Code
- U040202 NEPHROSTOMY KITS, SELDINGER METHOD EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Drainage Catheter & Sets by Allwin Medical Devices, Inc. — 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 | 081226101DCS007LH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Allwin Medical Devices, Inc
- EUDAMED SRN
- US-MF-000011349
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED ec6b353c-b57e-43fd-a1de-a73298aeac50 61 fields · synced Jul 10, 2026