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SpiroSafe Disposable Flow Transducers
EUDAMEDClass IIa (EU MDR)
Ref M9256-100Model M9256Ref M9256-SP-50Ref M9242-B-100Model M9242-BRef M9256-SP-90Ref M9242-B-SP-90Ref M9256-A-100Model M9256-A
by Medikro Oy
Identity
- Trade Name
- SpiroSafe Disposable Flow Transducers EUDAMED
- Device Name
- Medikro® SpiroSafe Disposable Flow Transducer EUDAMEDSpiroSafe Disposable Flow Transducer EUDAMED
- Model / Reference
- M9256 EUDAMEDM9256-100 EUDAMEDM9256-SP-50 EUDAMEDM9242-B EUDAMEDM9242-B-100 EUDAMEDM9256-SP-90 EUDAMEDM9242-B-SP-90 EUDAMEDM9256-A EUDAMEDM9256-A-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-M9256-1008Y EUDAMED06420099001209 EUDAMEDD-M9242-B-100FL EUDAMEDD-M9256-SP-90XT EUDAMEDD-M9242-B-SP-90HC EUDAMEDD-M9256-A-100HY EUDAMEDD-M9256-SP-50XF EUDAMED
- Basic UDI-DI
- B-M9256-1008Y EUDAMED6420099M9256L6 EUDAMEDB-M9242-B-100FL EUDAMEDB-M9256-SP-90XT EUDAMEDB-M9242-B-SP-90HC EUDAMEDB-M9256-A-100HY EUDAMEDB-M9256-SP-50XF EUDAMED
- Unit of Use DI
- 06420099000967 EUDAMED
- EMDN Code
- Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Category: Pulmonary function testing filter/mouthpiece
SpiroSafe Disposable Flow Transducers by Medikro Oy — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulmonary function testing filter/mouthpiece.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-M9256-1008Y | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-M9256-1008Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medikro Oy
- EUDAMED SRN
- FI-MF-000011841
Sources (7)
- EUDAMED b1ec3993-60a6-4dec-9d6c-524a568bdb4a 61 fields · synced Jul 30, 2026
- EUDAMED bb923c0a-5e5b-4075-9c67-33ef6818ec29 61 fields · synced May 17, 2026
- EUDAMED 5d43d690-37de-4af9-b870-a5730c96b6d5 61 fields · synced May 18, 2026
- EUDAMED 5ff837ef-4ec9-4933-b72d-1c8b17ec93e8 61 fields · synced May 18, 2026
- EUDAMED 56d29070-f7f7-4d12-b72b-29ab8c3d55fe 61 fields · synced May 18, 2026
- EUDAMED fdc3a318-996f-4df8-808f-b1a231a61845 61 fields · synced May 18, 2026
- EUDAMED 9c018d4a-1ac6-4e0f-bcef-363cbd2eb0c4 61 fields · synced May 19, 2026