Identity
- Trade Name
- EasyOne Filter SP, 100 pcs EUDAMEDEasyOne Filter SP FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- Filter EUDAMED
- Model / Reference
- 2091-412 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640142190882 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014219Filter2J EUDAMED
- Direct Marketing DI
- 07640142190882 EUDAMED
- 510(k) Number
- K221250 FDA UDI
- FDA Product Code
- CAH FDA UDI
- EMDN Code
- Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Pulmonary function testing filter/mouthpiece FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5260 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Pulmonary function testing filter/mouthpiece
EasyOne Filter SP by NDD Medizintechnik AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K221250 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- NDD Medizintechnik AG
Sources (2)
- FDA UDI cdcdcd21-bd05-4d36-9a13-22fa14751c13 33 fields · synced Jul 9, 2026
- EUDAMED 1685d341-d402-4b48-9a00-0d3544b7686f 61 fields · synced Jul 9, 2026