EKG-Papiere GE Hellige Cardiosmat, MAC1200, MAC1600 210 mm x 300 mm x 150 Bl, zu 22616605 (US)
by Diagramm Halbach GmbH & Co. KG
Ref 710040
Active
CE MDR 510(k)
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number42501236700100CL 04251801930690 | Date5 Dec 2024 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK950989 | Date13 May 1996 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Device Name
- Registrierpapiere (EKG, CTG und EEG) mit Messfunktion
- Model / Reference
- 710040
- Primary DI / UDI-DI
- 04251801930690
- Basic UDI-DI
- 42501236700100CL
- EMDN Code
- Z1302 Diagnostic registration papers
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000012732
Other devices from Diagramm Halbach GmbH & Co. KG
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No