Identity
- Trade Name
- PADSY Ergo 2.16 EUDAMEDPADSY Ergo EUDAMED
- Device Name
- PADSY Ergo EUDAMEDPADSY Ergo 2.15 EUDAMED
- Model / Reference
- AAG137120 EUDAMEDAAG137111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250403730226 EUDAMED04250403730219 EUDAMED
- Basic UDI-DI
- 42504037AAG137000-00CK EUDAMEDB-04250403730219 EUDAMED
- Direct Marketing DI
- 04250403730226 EUDAMED
- EMDN Code
- Z12050192 STRESS ANALYSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED-1192 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 Ergo 2.16 by Medset Medizintechnik GmbH — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 42504037AAG137000-00CK | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 42504037AAG137000-00CK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medset Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000016442
Sources (2)
- EUDAMED c4ad71c4-9540-49c6-9079-299c83f05b52 61 fields · synced Jul 14, 2026
- EUDAMED 01cb6bce-57fb-41ce-b410-873462bdf020 61 fields · synced May 19, 2026