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PADSY Holter
EUDAMEDClass IIa (EU MDR)
Ref AAG118100Ref AAG118100-02Ref AAG118102
Identity
- Trade Name
- PADSY Holter EUDAMEDPADSY Holter 4.6 EUDAMED
- Device Name
- PADSY Holter 4.5 EUDAMEDPADSY Holter 4.4 EUDAMEDPADSY Holter EUDAMED
- Model / Reference
- AAG118100 EUDAMEDAAG118100-02 EUDAMEDAAG118102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250403710211 EUDAMED04250403710204 EUDAMED04250403710228 EUDAMED
- Basic UDI-DI
- B-04250403710211 EUDAMEDB-04250403710204 EUDAMED42504037AAG118000-01BY EUDAMED
- Direct Marketing DI
- 04250403710228 EUDAMED
- EMDN Code
- Z12050492 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMEDSoftware 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 Holter by Medset Medizintechnik GmbH — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250403710211 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250403710211 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medset Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000016442
Sources (3)
- EUDAMED d71afa78-4b22-484e-a229-f1410302ac66 61 fields · synced Jul 13, 2026
- EUDAMED 7313d2a7-4490-4758-b1ea-1c4bed614c1c 61 fields · synced May 18, 2026
- EUDAMED 3bab85d9-f2b8-48d2-9e20-42b5196e5d23 61 fields · synced May 19, 2026