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ECG, Respiration and SpO2 Transmitter model LX-8300M type LX-8300M
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref LX-8300M
Identity
- Trade Name
- ECG, Respiration and SpO2 Transmitter model LX-8300M type LX-8300M EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Measuring and Monitoring Equipment for Vital Signs EUDAMED
- Model / Reference
- LX-8300M EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612914584 EUDAMED04538612914591 FDA UDI
- Basic UDI-DI
- 4538612022009X EUDAMED
- 510(k) Number
- K103134 FDA UDI
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z12050803 ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Italy 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
ECG, Respiration and SpO2 Transmitter model LX-8300M type LX-8300M by Fukuda Denshi Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 4538612022009X | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Fukuda Denshi Co., Ltd.
- EUDAMED SRN
- JP-MF-000008253
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 76452659-7e35-405d-91c6-34f0fefb5190 61 fields · synced Jul 24, 2026
- FDA UDI b28aaa67-3f68-4550-bf70-ea91544d7c63 33 fields · synced May 30, 2026