Identity
- Trade Name
- Fenom Pro EUDAMEDCAIRE Diagnostics FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- Fractional Exhaled Nitric Oxide Breath Analyzer EUDAMEDPackage contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for EU Instructions for Use, Fenom Pro, - P/N IFU-3264 AC Power Cord Cable, Europlug - PN 415-0011 FDA UDI
- Model / Reference
- 900-0001 EUDAMED900-0007 EUDAMEDFenom Pro, EU FDA UDI
- Description
- Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for EU Instructions for Use, Fenom Pro, - P/N IFU-3264 AC Power Cord Cable, Europlug - PN 415-0011 FDA UDI
Identifiers
- Catalog Number
- 900-0007 FDA UDI
- Primary DI / UDI-DI
- 00860008017925 EUDAMEDFDA UDI
- Basic UDI-DI
- 8600080179FenomPro,EUVU EUDAMED
- Direct Marketing DI
- 00860008017925 EUDAMED
- 510(k) Number
- K182874 FDA UDI
- FDA Product Code
- MXA FDA UDI
- EMDN Code
- W02079099 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3080 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fenom Pro by CAIRE Diagnostics Inc. — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213611 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 8600080179FenomPro,EUVU | Class A | Active |
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Manufacturer
- Manufacturer
- CAIRE Diagnostics Inc.
- EUDAMED SRN
- US-MF-000030745
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (3)
- EUDAMED 3f59311a-3379-4d2c-a602-c9bcb4a93283 61 fields · synced Jun 20, 2026
- FDA UDI 10c7a5ce-97c9-40ad-b937-a45de20ee938 35 fields · synced May 29, 2026
- FDA 510(k) K213611 1 fields · synced May 18, 2026