← Back to catalogue
LX-1000 Series ECG, Respiration and SpO2 Transmitter LX-1300
EUDAMEDClass IIb (EU MDR)
Ref LX-1300N
Identity
- Trade Name
- LX-1000 Series ECG, Respiration and SpO2 Transmitter LX-1300 EUDAMED
- Device Name
- Measuring and Monitoring Equipment for Vital Signs EUDAMED
- Model / Reference
- LX-1300N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612916298 EUDAMED
- Basic UDI-DI
- 4538612022009X EUDAMED
- EMDN Code
- Z12050803 ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS EUDAMEDZ1203020603 VITAL SIGNS TELEMETRY TRANSMITTER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
LX-1000 Series ECG, Respiration and SpO2 Transmitter LX-1300 by Fukuda Denshi Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4538612022009X | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fukuda Denshi Co., Ltd.
- EUDAMED SRN
- JP-MF-000008253
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c553479e-714e-42c0-bdb1-b2387e665707 61 fields · synced Oct 8, 2026
- EUDAMED 6f5a675d-a9b3-45de-9057-d4b89d40791f 61 fields · synced Oct 8, 2026