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CardioMem CM 4000B
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 84101Model CardioMem CM 4000B
Identity
- Trade Name
- CardioMem CM 4000B EUDAMED
- Device Name
- CardioMem CM 4000B EUDAMED
- Model / Reference
- CardioMem CM 4000B EUDAMED84101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250903203381 EUDAMED
- Basic UDI-DI
- B-04250903203381 EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CardioMem CM 4000B by Getemed Medizin- Und Informationstechnik Ag — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122272 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250903203381 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GETEMED Medizin- und Informationstechnik AG
- EUDAMED SRN
- DE-MF-000012384
Sources (2)
- EUDAMED 8818d638-380f-4ccd-a626-d6564a362b0f 61 fields · synced Jul 16, 2026
- FDA 510(k) K122272 1 fields · synced May 18, 2026