Identity
- Trade Name
- Spirette box of 500 pcs EUDAMEDspirette FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- Breathing mouthpieces EUDAMED
- Model / Reference
- 2050-10 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640142190400 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014219mouthpiece24 EUDAMED
- Direct Marketing DI
- 07640142190400 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 FDA 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 by NDD Medizintechnik AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NDD Medizintechnik AG
Sources (2)
- FDA UDI c5be55c4-7ed8-4607-b3a0-3bd889a17b08 33 fields · synced Jul 22, 2026
- EUDAMED 94b5de16-8a9d-4b1c-8ab4-ebf11bcbb42e 61 fields · synced Jul 22, 2026