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SpiroSafe Disposable Flow Transducers
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref M9256-100Model M9256
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 EUDAMEDM9256-100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06420099000554 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
SpiroSafe Disposable Flow Transducers by Medikro Oy — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 2f799e21-166e-47c3-9331-d65a5abf0f41 61 fields · synced Aug 2, 2026
- FDA UDI b1407bc3-e1b5-4dea-80c7-e727f6401afd 32 fields · synced May 30, 2026