← Back to catalogue
Spirolyser Q13
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FF1153Model Spirolyser Q13 Depisteo
by FIM Médical
Identity
- Trade Name
- Spirolyser Q13 EUDAMEDQ13 DEPISTEO Spirolyser FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- Spirolyser Q13 Depisteo EUDAMED
- Model / Reference
- Spirolyser Q13 Depisteo EUDAMEDFF1153 EUDAMEDFF1153 Q13 Depisteo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760253450522 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760253450522 EUDAMED
- 510(k) Number
- K161676 FDA UDI
- FDA Product Code
- BZG FDA UDI
- EMDN Code
- Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS EUDAMED
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Spirolyser Q13 by FIM Medical — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760253450522 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FIM Médical
- EUDAMED SRN
- FR-MF-000017090
Sources (2)
- EUDAMED 97cca89a-d61f-4f79-8e94-2e4c41cd2460 61 fields · synced Jun 17, 2026
- FDA UDI 57370a71-4769-4268-96bc-ca2d6cb22cc8 34 fields · synced May 30, 2026