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Central Monitor CNS-2101
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref CNS-2101K
Identity
- Trade Name
- Central Monitor CNS-2101 EUDAMEDCNS-2101 Central Monitor FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- Centralized patient monitor EUDAMEDCentral Monitor FDA UDI
- Model / Reference
- CNS-2101K EUDAMEDCNS-2101 FDA UDI
- Description
- Central Monitor FDA UDI
Identifiers
- Catalog Number
- CNS-2101 FDA UDI
- Primary DI / UDI-DI
- 04931921017166 EUDAMEDFDA UDI
- Basic UDI-DI
- 4931921MD2b0003LW EUDAMED
- Direct Marketing DI
- 04931921017166 EUDAMED
- FDA Product Code
- MSX FDA UDIDRQ FDA UDIMWI FDA UDI
- EMDN Code
- Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED
- GMDN Term
- Centralized patient monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI870.2060 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Central Monitor CNS-2101 by Nihon Kohden Corporation — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223567 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 4931921MD2b0003LW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden Corporation
- EUDAMED SRN
- JP-MF-000019022
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (3)
- EUDAMED bb2687ab-561d-4604-9b3a-8e30ea16c2a2 61 fields · synced Oct 6, 2026
- FDA UDI 081b4450-55f1-4489-8caf-6a025acec545 35 fields · synced May 29, 2026
- FDA 510(k) K223567 1 fields · synced May 18, 2026