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Smart Peak Flow
EUDAMEDClass IIa (EU MDR)
Ref Smart Peak Flow Graphite - Single Unit
Identity
- Device Name
- Smart Peak Flow EUDAMED
- Model / Reference
- Smart Peak Flow Graphite - Single Unit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05999887746475 EUDAMED
- Basic UDI-DI
- B-05999887746475 EUDAMED
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Expiratory peak flow meter, digital
Smart Peak Flow by Smart Respiratory Products Ltd. — Class IIa — MDD — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05999887746475 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Smart Respiratory Products Ltd.
- EUDAMED SRN
- GB-MF-000018053
- Authorised Representative
- Smart Respiratory Manufacturing Kft. HU-AR-000016191
Sources (1)
- EUDAMED c12621aa-ce5b-45c1-9d15-0eaa5acf712f 61 fields · synced Jun 19, 2026