Medikro Pressure Tube
EUDAMEDFDA UDIClass I (EU MDR)
by Medikro Oy
Identity
- Trade Name
- Medikro Pressure Tube EUDAMEDM9264-200, Pressure Tube FDA UDI
- Generic Name
- Spirometry/pulmonary function pressure tube FDA UDI
- Model / Reference
- M9264 EUDAMEDM9264-200 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06420099000486 EUDAMEDFDA UDI
- Basic UDI-DI
- 6420099M9264L5 EUDAMED
- FDA Product Code
- BYX FDA UDI
- EMDN Code
- Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Spirometry/pulmonary function pressure tube FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5860 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Pulmonary function testing filter/mouthpiece
Medikro Pressure Tube by Medikro Oy — Class I — 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 | 6420099M9264L5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medikro Oy
- EUDAMED SRN
- FI-MF-000011841
Sources (2)
- EUDAMED e47f603d-e2f5-4772-b9dd-98098892af6c 61 fields · synced May 31, 2026
- FDA UDI 8444bedc-9dd9-47d1-8629-4830d775d5b2 32 fields · synced May 29, 2026