Identity
- Trade Name
- PADSY Spiro 1.5 EUDAMED
- Device Name
- PADSY Spiro EUDAMED
- Model / Reference
- AAG147103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250403740058 EUDAMED
- Basic UDI-DI
- 42504037AAG147000-00D6 EUDAMED
- Direct Marketing DI
- 04250403740058 EUDAMED
- EMDN Code
- Z12150192 SPIROMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
PADSY Spiro 1.5 by Medset Medizintechnik 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 | 42504037AAG147000-00D6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medset Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000016442
Sources (1)
- EUDAMED 1697cc23-d50a-4091-9894-b7c9e6d46625 61 fields · synced Aug 1, 2026