Identity
- Trade Name
- SpiroDef SP-250 EUDAMED
- Device Name
- SpiroDef Filter EUDAMED
- Model / Reference
- SpiroDef Filter EUDAMED019420662 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613365500158 EUDAMED
- Basic UDI-DI
- 7613365SPDEF32 EUDAMED
- Direct Marketing DI
- 07613365500158 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 SP-250 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 481fbae0-c917-4c06-94de-081a03cdc0e6 61 fields · synced Jun 19, 2026