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CNAP Monitor 500 HD
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 21-FHCN-1552Model CNAP Monitor 500 HD
Identity
- Trade Name
- CNAP Monitor 500 HD EUDAMED
- Model / Reference
- CNAP Monitor 500 HD EUDAMED21-FHCN-1552 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120073932235 EUDAMED
- Basic UDI-DI
- B-09120073932235 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
CNAP Monitor 500 HD by CNSYSTEMS MEDIZINTECHNIK GmbH — Class IIb — 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 | K183521 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-09120073932235 | Class IIb | Active |
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Manufacturer
- Manufacturer
- CNSystems Medizintechnik GmbH
- EUDAMED SRN
- AT-MF-000001033
Sources (2)
- EUDAMED 650a958b-7b14-4952-8536-e896f5f8f519 61 fields · synced Oct 6, 2026
- FDA 510(k) K183521 1 fields · synced May 18, 2026