Identity
- Trade Name
- DUO NPWTi Port Pad EUDAMED
- Device Name
- DUO NPWTi Port Pad EUDAMED
- Model / Reference
- DP-2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849405002475 EUDAMED
- Basic UDI-DI
- B-00849405002475 EUDAMED
- EMDN Code
- A070103 INFUSION TUBING ADAPTERS AND CONNECTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
DUO NPWTi Port Pad by Genadyne Biotechnologies Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00849405002475 | Class I | Active |
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Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
- EUDAMED SRN
- US-MF-000017992
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED b5569358-6efe-41a5-8067-a2bd8b7476ab 61 fields · synced Jun 19, 2026