Identity
- Trade Name
- Spirette (basic unit) EUDAMEDSpirette M (basic unit) EUDAMEDspirette m FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- Breathing mouthpieces EUDAMEDBreathing tubes EUDAMED
- Model / Reference
- 2050-0 EUDAMED2050-7 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640142190486 EUDAMED07640142190271 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014219mouthpiece24 EUDAMED764014219BreathingTubes6L EUDAMED
- FDA Product Code
- BYP FDA UDI
- EMDN Code
- Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Pulmonary function testing filter/mouthpiece FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 868.5620 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary function testing filter/mouthpiece
Spirette (basic unit) by NDD Medizintechnik AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 764014219mouthpiece24 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- NDD Medizintechnik AG
- EUDAMED SRN
- CH-MF-000015550
- Authorised Representative
- NDD Medizintechnik GmbH DE-AR-000032322
Sources (3)
- EUDAMED 755538fb-dabf-4b30-a048-439adccaf237 61 fields · synced Jul 31, 2026
- FDA UDI b8821b0f-b37e-424c-921a-8767e99c20f4 33 fields · synced May 30, 2026
- EUDAMED 90f6de8c-c7cb-4786-b4e4-2b53ed933780 61 fields · synced Jul 31, 2026