Identity
- Trade Name
- Mounting Bracket for LW-1000 EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- Portable active medical device mount FDA UDI
- Device Name
- Reusable Accessories Measuring and Monitoring Device for Vital Signs EUDAMED
- Model / Reference
- OAO-1012A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612230332 EUDAMEDFDA UDI
- Basic UDI-DI
- 453861202301A6 EUDAMED
- FDA Product Code
- DSI FDA UDI
- EMDN Code
- Z12030602 EUDAMED
- GMDN Term
- Portable active medical device mount FDA UDI
Classification
- Device Class
- Class I 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mounting Bracket for LW-1000 by Fukuda Denshi Co., Ltd. — 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 | 453861202301A6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 a92116f4-6937-402a-a156-15345d11a7f1 61 fields · synced Jun 18, 2026
- FDA UDI e41d7a4c-e421-43d0-8f60-cadfc84e31ce 32 fields · synced May 29, 2026