Identity
- Trade Name
- Fenom Pro EUDAMEDCAIRE Diagnostics FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- Fenom Pro Mouthpiece EUDAMEDBox of 50 Fenom Pro Mouthpieces, PN 810-0006 Sold in box of 50 only, individual mouthpieces are not for retail or commercial sale Each mouthpiece is individually packaged FDA UDI
- Model / Reference
- 900-0019-50 EUDAMEDFenom Pro Mouthpieces, Box of 50 FDA UDI
- Description
- Box of 50 Fenom Pro Mouthpieces, PN 810-0006 Sold in box of 50 only, individual mouthpieces are not for retail or commercial sale Each mouthpiece is individually packaged FDA UDI
Identifiers
- Catalog Number
- 900-0019-50 FDA UDI
- Primary DI / UDI-DI
- 00860008017956 EUDAMEDFDA UDI
- Basic UDI-DI
- 8600080179FenomDW EUDAMED
- Direct Marketing DI
- 00860008017956 EUDAMED
- 510(k) Number
- K182874 FDA UDI
- FDA Product Code
- MXA FDA UDI
- EMDN Code
- R9001 RESPIRATORY MOUTHPIECES EUDAMED
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class I 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
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Fenom Pro by CAIRE Diagnostics Inc. — Class I — 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 | 8600080179FenomDW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 77cf3b82-c2c5-4b5c-ad24-2580b25ed48c 61 fields · synced Jul 10, 2026
- FDA UDI ebd7ecef-d3ec-46ed-abdd-f6618ae27047 35 fields · synced May 30, 2026