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PowerCube+ Series
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 050000000Model PowerCube+ Series
Identity
- Trade Name
- PowerCube+ Series EUDAMEDFDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- The PowerCube Diffusion+ is equipped with the MultiX Trolley. FDA UDI
- Model / Reference
- PowerCube+ Series EUDAMED050000000 EUDAMEDA FDA UDI
- Description
- The PowerCube Diffusion+ is equipped with the MultiX Trolley. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613365500301 EUDAMEDFDA UDI
- Basic UDI-DI
- 7613365PWCBD2Y EUDAMED
- Direct Marketing DI
- 07613365500301 EUDAMED
- FDA Product Code
- JEH FDA UDIBZG FDA UDI
- EMDN Code
- Z12159003 DIFFUSION ANALYSIS EQUIPMENT EUDAMED
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1760 FDA UDI868.1840 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PowerCube+ Series by Ganshorn Medizin Electronic Gmbh — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7613365PWCBD2Y | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ganshorn Medizin Electronic GmbH
- EUDAMED SRN
- DE-MF-000006566
Sources (2)
- EUDAMED 552da6bb-c7b5-40cd-91eb-01cd29696e68 61 fields · synced May 30, 2026
- FDA UDI dc5c553f-99ef-45eb-a467-84daf4fe88cd 34 fields · synced May 30, 2026