Identity
- Trade Name
- Easy on-PC EUDAMEDFDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- Spirometry Family EUDAMED
- Model / Reference
- 2700-3 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 2700-3 FDA UDI
- Primary DI / UDI-DI
- 07640142190301 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014219SpirometerBS EUDAMED
- Direct Marketing DI
- 07640142190301 EUDAMED
- 510(k) Number
- K090034 FDA UDI
- FDA Product Code
- BZG FDA UDI
- EMDN Code
- Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS 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
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
Yes
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
Category: Diagnostic spirometer, professional
Easy on-PC 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
K090034 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 ec5b5186-fa44-4f24-b4d6-19be45962ff8 36 fields · synced Jul 26, 2026
- EUDAMED cddaa811-5018-4221-a4b3-82e3e7c5a728 61 fields · synced Jul 26, 2026