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Tri-ball Incentive Spirometer
EUDAMEDClass I (EU MDR)
Ref AL0014Model (F) Spirometry
Identity
- Trade Name
- Tri-ball Incentive Spirometer EUDAMED
- Device Name
- Incentive Spirometer EUDAMED
- Model / Reference
- (F) Spirometry EUDAMEDAL0014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24710810087596 EUDAMED
- Basic UDI-DI
- 471081008NNF17A EUDAMED
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Expiratory peak flow meter, digital
Tri-ball Incentive Spirometer by GaleMed Corporation — Class I — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471081008NNF17A | Class I | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 10e43710-41d6-48eb-b1a0-8134251240cd 61 fields · synced Aug 1, 2026