SpiroSafe Disposable Flow Transducers
EUDAMEDFDA UDIClass IIa (EU MDR)
by Medikro Oy
Identity
- Trade Name
- SpiroSafe Disposable Flow Transducers EUDAMEDM9256, SpiroSafe Disposable Flow Transducer FDA UDI
- Generic Name
- Breathing mouthpiece, single-use FDA UDI
- Device Name
- SpiroSafe Disposable Flow Transducer EUDAMED
- Model / Reference
- M9256 EUDAMEDM9256-SP-90 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06420099000561 EUDAMEDFDA UDI
- Basic UDI-DI
- 6420099M9256L6 EUDAMED
- Unit of Use DI
- 06420099000967 EUDAMED
- FDA Product Code
- BYP FDA UDI
- EMDN Code
- Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Breathing mouthpiece, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5620 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Pulmonary function testing filter/mouthpiece
SpiroSafe Disposable Flow Transducers by Medikro Oy — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6420099M9256L6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medikro Oy
- EUDAMED SRN
- FI-MF-000011841
Sources (2)
- EUDAMED 8800a872-6b10-4c83-8e85-eb4486d77bc3 61 fields · synced Jun 19, 2026
- FDA UDI 90efd723-48a5-4af6-a5df-cb5a7838477b 32 fields · synced May 29, 2026