Recorder Cable, 10M YS-108P2
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Recorder Cable, 10M YS-108P2 EUDAMEDNA FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- General-purpose multi-parameter bedside monitor EUDAMEDRecorder Cable, G9 FDA UDI
- Model / Reference
- YS-108P3 EUDAMEDYS-108P2 EUDAMEDFDA UDI
- Description
- Recorder Cable, G9 FDA UDI
Identifiers
- Catalog Number
- YS-108P2 FDA UDI
- Primary DI / UDI-DI
- 04931921112595 EUDAMEDFDA UDI
- Basic UDI-DI
- 4931921MD10004BD EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General-purpose multi-parameter bedside monitor
Recorder Cable, 10M YS-108P2 by Nihon Kohden Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4931921MD10004BD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 f44a5de0-2857-4b20-a33a-9685e0eadf19 61 fields · synced Jul 21, 2026
- FDA UDI 52f81fa2-3123-46a9-9e7c-97425868fede 35 fields · synced May 29, 2026
- EUDAMED 576ecd95-fdd5-47fc-83d7-b21e0066c77c 61 fields · synced Jul 21, 2026