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SpiroDef Mouthpiece
EUDAMEDClass IIa (EU MDR)
Ref 019420660Model SpiroDef Filter
Identity
- Trade Name
- SpiroDef Mouthpiece EUDAMED
- Device Name
- SpiroDef Filter EUDAMED
- Model / Reference
- SpiroDef Filter EUDAMED019420660 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613365500110 EUDAMED
- Basic UDI-DI
- 7613365SPDEF32 EUDAMED
- Direct Marketing DI
- 07613365500110 EUDAMED
- EMDN Code
- R049001 PULMONARY FUNCTION TEST FILTERS 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
SpiroDef Mouthpiece by Ganshorn Medizin Electronic Gmbh — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 7613365SPDEF32 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ganshorn Medizin Electronic GmbH
- EUDAMED SRN
- DE-MF-000006566
Sources (1)
- EUDAMED eff571ad-d737-450f-99e7-1dc2b0520f58 61 fields · synced Jul 18, 2026