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Spirolyser Q13
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref FF1037Model Spirolyser Q13
by FIM Medical
Identity
- Trade Name
- Spirolyser Q13 EUDAMEDSpirolyser FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- Spirolyser Q13 EUDAMED
- Model / Reference
- Spirolyser Q13 EUDAMEDFF1037 EUDAMEDQ13 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760253450003 EUDAMEDFDA UDI
- Basic UDI-DI
- 376025345FF1037TL EUDAMEDB-03760253450003 EUDAMED
- Direct Marketing DI
- 03760253450003 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
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
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_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 376025345FF1037TL | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K161676 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 376025345FF1037TL | Class IIa | Active |
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Manufacturer
- Manufacturer
- FIM Medical
- EUDAMED SRN
- FR-MF-000017090
Sources (4)
- EUDAMED 93c00205-9bb5-4292-acb4-3a30b4c7e900 61 fields · synced Jul 20, 2026
- EUDAMED e61ed62a-7678-490f-9b94-b5a1392c549f 61 fields · synced May 18, 2026
- FDA UDI 382e90b6-f376-4fa0-b92d-81c8a87cfaff 34 fields · synced May 30, 2026
- FDA 510(k) K161676 1 fields · synced May 18, 2026