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Battery Pack SB-950P
EUDAMEDFDA UDIClass I (EU MDR)
Ref SB-950P-CL SB-950P-DB SB-950P-DB-30
Identity
- Trade Name
- Battery Pack SB-950P EUDAMEDNihon Kohden Life Scope G5 Bedside Monitoring System FDA UDI
- Generic Name
- Portable/mobile rechargeable battery pack FDA UDI
- Device Name
- General-purpose multi-parameter bedside monitor EUDAMEDBattery pack (for CU-151R, CU-152R) FDA UDI
- Model / Reference
- SB-950P-CL SB-950P-DB SB-950P-DB-30 EUDAMEDSB-950P FDA UDI
- Description
- Battery pack (for CU-151R, CU-152R) FDA UDI
Identifiers
- Catalog Number
- SB-950P FDA UDI
- Primary DI / UDI-DI
- 04931921023624 EUDAMEDFDA UDI04931921041857 EUDAMED
- Basic UDI-DI
- 4931921MD10004BD EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Portable/mobile rechargeable battery pack 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Battery Pack SB-950P by Nihon Kohden Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 01b96c56-3f20-4644-a516-52a9332de8f0 61 fields · synced Oct 5, 2026
- EUDAMED 29d13359-f901-443b-9b6b-0081691dab7f 61 fields · synced May 18, 2026
- FDA UDI 370f1f1d-5c90-45fe-b11a-81cd892a46b5 35 fields · synced May 30, 2026