Identity
- Trade Name
- SPLY SPIRETTES #50 EUDAMED
- Device Name
- Breathing mouthpieces EUDAMED
- Model / Reference
- 2050-1GE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142190523 EUDAMED
- Basic UDI-DI
- 764014219mouthpiece24 EUDAMED
- Direct Marketing DI
- 07640142190523 EUDAMED
- EMDN Code
- Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Pulmonary function testing filter/mouthpiece
Sply Spirettes #50 by NDD Medizintechnik AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulmonary function testing filter/mouthpiece.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764014219mouthpiece24 | Class IIa | Active |
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Manufacturer
- Manufacturer
- NDD Medizintechnik AG
- EUDAMED SRN
- CH-MF-000015550
- Authorised Representative
- NDD Medizintechnik GmbH DE-AR-000032322
Sources (1)
- EUDAMED 0b891215-213e-4254-bd43-1bf199783b21 61 fields · synced Jul 31, 2026