Identity
- Trade Name
- UBREATH EUDAMED
- Device Name
- Patient Filters EUDAMED
- Model / Reference
- TF711 EUDAMEDTF721 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971404133790 EUDAMED
- Basic UDI-DI
- 69714041300203H EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Ubreath by E-Linkcare Meditech Co., Ltd. — Class I — 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 | 69714041300203H | Class I | Active |
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Manufacturer
- Manufacturer
- e-LinkCare Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000019475
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED b1a43c8b-cc13-4bbf-a03b-d1155d019699 61 fields · synced Jun 19, 2026