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Ubreath
EUDAMEDClass I (EU MDR)
Ref TF7112103Model TF711Ref BA2002101Model BA200
Identity
- Trade Name
- UBREATH EUDAMED
- Device Name
- Patient Filters EUDAMEDUBREATH® Breath Gas Test System EUDAMED
- Model / Reference
- TF711 EUDAMEDTF7112103 EUDAMEDBA200 EUDAMEDBA2002101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971404133783 EUDAMED06971404132588 EUDAMED
- Basic UDI-DI
- 69714041300203H EUDAMEDB-06971404132588 EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMEDW02010199 CHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Italy EUDAMEDFrance 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
Microbial Substances
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ubreath by E-Linkcare Meditech Co., Ltd. — Class I — IVDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69714041300203H | Class I | Active |
| 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 (2)
- EUDAMED a5f4b197-2a63-45ad-a767-374ef2aa6aff 61 fields · synced Jul 21, 2026
- EUDAMED 1c0b660e-3039-4c3d-80b1-9069e68e38a1 61 fields · synced May 17, 2026