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Central Telemetry Receiver LW-1000
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref LW-1080
Identity
- Trade Name
- Central Telemetry Receiver LW-1000 EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- Electrocardiography monitoring system receiver FDA UDI
- Device Name
- Measuring and Monitoring Device for Vital Signs EUDAMED
- Model / Reference
- LW-1080 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612915918 EUDAMED04538612915925 FDA UDI
- Basic UDI-DI
- 453861202300A4 EUDAMED
- FDA Product Code
- DSI FDA UDI
- EMDN Code
- Z12030602 EUDAMED
- GMDN Term
- Electrocardiography monitoring system receiver 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
Central Telemetry Receiver LW-1000 by Fukuda Denshi Co., Ltd. — Class IIb — 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 | 453861202300A4 | 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 1e1f5683-4f57-4f86-b7b2-4266e7dce7f8 61 fields · synced Jun 19, 2026
- FDA UDI a3acc8ab-bd1d-4cd9-ab43-5f1abcea0725 32 fields · synced May 29, 2026