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SpiroScout SP plus
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 013400563Model SpiroScout
Identity
- Trade Name
- SpiroScout SP plus EUDAMEDFDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- SpiroScout EUDAMEDThe SpiroScout SP plus is intended exclusively for use with the following SCHILLER devices. CARDIOVIT CS-104 SPIROVIT SP-1 G2 CARDIOVIT AT-102 G2 The SpiroScout SP plus is an ultrasonic measuring system which is used for pulmonary function diagnostics. It determines the transit times of the ultrasonic signals and can be used with the above-mentioned Schiller devices to measure and analyse respiratory flow and volume. FDA UDI
- Model / Reference
- SpiroScout EUDAMED013400563 EUDAMEDD FDA UDI
- Description
- The SpiroScout SP plus is intended exclusively for use with the following SCHILLER devices. CARDIOVIT CS-104 SPIROVIT SP-1 G2 CARDIOVIT AT-102 G2 The SpiroScout SP plus is an ultrasonic measuring system which is used for pulmonary function diagnostics. It determines the transit times of the ultrasonic signals and can be used with the above-mentioned Schiller devices to measure and analyse respiratory flow and volume. FDA UDI
Identifiers
- Catalog Number
- 013400563 FDA UDI
- Primary DI / UDI-DI
- 07613365500035 EUDAMEDFDA UDI
- Basic UDI-DI
- 7613365SPSCT63 EUDAMED
- FDA Product Code
- BZG FDA UDI
- EMDN Code
- Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS EUDAMED
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SpiroScout SP plus by Ganshorn Medizin Electronic Gmbh — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160116 | Class IIa | Active |
| 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 (3)
- EUDAMED ba315fc8-9f3b-48ef-b5b2-6b6ae9a51330 61 fields · synced Jun 19, 2026
- FDA UDI dbda722b-2a8b-4917-ba32-10aad1e145ae 36 fields · synced May 30, 2026
- FDA 510(k) K160116 1 fields · synced May 18, 2026