Identity
- Trade Name
- SpiroScout EUDAMED
- Device Name
- SpiroScout EUDAMED
- Model / Reference
- SpiroScout EUDAMED044210001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613365500028 EUDAMED
- Basic UDI-DI
- 7613365SPSCT63 EUDAMED
- Direct Marketing DI
- 07613365500028 EUDAMED
- EMDN Code
- Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SpiroScout 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 | 7613365SPSCT63 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ganshorn Medizin Electronic GmbH
- EUDAMED SRN
- DE-MF-000006566
Sources (1)
- EUDAMED 97894e52-25ca-44ca-ae96-a35b7828c893 61 fields · synced May 29, 2026