Identity
- Trade Name
- SpiroWay EUDAMEDFDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- iSpiro Ultrasonic Sensor EUDAMEDMouthpiece, accessory to spirometer FDA UDI
- Model / Reference
- 892114 EUDAMEDSpiroWay FDA UDI
- Description
- Mouthpiece, accessory to spirometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057155000801 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057155Z12150101004C9 EUDAMED
- 510(k) Number
- K213754 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
Yes
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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
SpiroWay by eResearchTechnology GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4057155Z12150101004C9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- eResearchTechnology GmbH
- EUDAMED SRN
- DE-MF-000008015
Sources (2)
- EUDAMED 2977e76f-274c-41e1-a7d9-29a3dc931df6 61 fields · synced Jul 23, 2026
- FDA UDI 6c56197d-27b7-440f-9bc7-8a07bfaac15a 35 fields · synced May 29, 2026