Identity
- Device Name
- Heated-wire circuit EUDAMED
- Model / Reference
- 3411 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873290055 EUDAMED
- Basic UDI-DI
- 47198732930VR EUDAMED
- Direct Marketing DI
- 04719873290055 EUDAMED
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Heated-wire circuit by Da Chung Medical 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 | 47198732930VR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Da Chung Medical Co., Ltd.
- EUDAMED SRN
- TW-MF-000037960
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED ef555f46-396c-462e-9eb1-06f1428bfc58 61 fields · synced Jun 19, 2026