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Ergofilter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SP1MModel Ergofilter SP1M
by FIM Medical
Identity
- Trade Name
- Ergofilter EUDAMEDFDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- Ergofilter SP1M EUDAMEDaccessory to active diagnostic devices: FIM Spirometers FDA UDI
- Model / Reference
- Ergofilter SP1M EUDAMEDSP1M EUDAMEDFDA UDI
- Description
- accessory to active diagnostic devices: FIM Spirometers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760253450386 EUDAMED03760253450645 FDA UDI
- Basic UDI-DI
- B-03760253450386 EUDAMED
- 510(k) Number
- K161676 FDA UDI
- FDA Product Code
- BZG FDA UDI
- EMDN Code
- Z1399 NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Pulmonary function testing filter/mouthpiece 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
Yes
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
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
Yes
FDA UDI
Ergofilter 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-03760253450386 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- FIM Medical
- EUDAMED SRN
- FR-MF-000017090
Sources (2)
- EUDAMED 1907cc5b-f745-4c32-9d65-e19a859641cb 61 fields · synced Jul 15, 2026
- FDA UDI f8435a9d-6884-4050-84e1-b4b6b9af898e 35 fields · synced May 30, 2026