EasyOne Air Diagnostic Spirometer
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EasyOne Air EUDAMEDEasyOne Air Diagnostic Spirometer FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- Spirometry Family EUDAMED
- Model / Reference
- 2500-2 EUDAMED2500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640142190431 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014219SpirometerBS EUDAMED
- Direct Marketing DI
- 07640142190431 EUDAMED
- 510(k) Number
- K161536 FDA UDI
- FDA Product Code
- BZG FDA UDI
- EMDN Code
- Z12150180 SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Yes
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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Diagnostic spirometer, professional
EasyOne Air Diagnostic Spirometer 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
K161536 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 5783c2c8-44cd-4d7d-b354-dc7cdbc4ce4a 35 fields · synced Jul 14, 2026
- EUDAMED be756a1e-8548-41df-a160-178328f91bb8 61 fields · synced Jul 14, 2026