Identity
- Trade Name
- Lung Exerciser EUDAMED
- Device Name
- Lung Exerciser EUDAMED
- Model / Reference
- LEX-2 EUDAMEDLEX EUDAMED
Identifiers
- Primary DI / UDI-DI
- LEXS9 EUDAMEDD-LEX-2YZ EUDAMED
- Basic UDI-DI
- ++G401LEXS9 EUDAMEDB-LEX-2YZ EUDAMED
- Direct Marketing DI
- LEXS9 EUDAMED
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus 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
Category: Expiratory peak flow meter, digital
Lung Exerciser by Disposafe Health & Lifecare Limited — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Expiratory peak flow meter, digital.
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- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | ++G401LEXS9 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++G401LEXS9 | Class I | Active |
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Manufacturer
- Manufacturer
- Disposafe Health & Lifecare Limited
- EUDAMED SRN
- IN-MF-000020265
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 7da730ad-b60a-42bc-9471-52e7f6c60676 61 fields · synced Jul 11, 2026
- EUDAMED 1a8002de-2309-4959-b62d-cdf8956a644e 61 fields · synced May 17, 2026