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PhysioGate PG 2000
EUDAMEDClass IIa (EU MDR)
Ref 79313021Model PhysioGate PG 2000
Identity
- Trade Name
- PhysioGate PG 2000 EUDAMED
- Device Name
- PhysioGate PG 2000 EUDAMED
- Model / Reference
- PhysioGate PG 2000 EUDAMED79313021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250903202490 EUDAMED
- Basic UDI-DI
- B-04250903202490 EUDAMED
- EMDN Code
- Z12050492 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PhysioGate PG 2000 by Getemed Medizin- Und Informationstechnik Ag — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250903202490 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GETEMED Medizin- und Informationstechnik AG
- EUDAMED SRN
- DE-MF-000012384
Sources (1)
- EUDAMED be9f4438-1fd2-4f90-ad9a-05f378f09eb8 61 fields · synced Jul 12, 2026