Identity
- Trade Name
- DynaBase EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- Model / Reference
- CVW-6000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612907395 EUDAMEDFDA UDI
- Basic UDI-DI
- 453861204100A8 EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- Z12030282 VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
DynaBase 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 | 453861204100A8 | 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 59bbb634-68b0-47db-a95b-4ebe3acd64fb 61 fields · synced Jul 25, 2026
- FDA UDI cc348167-8b87-4992-896c-dfb47ae8f7e0 32 fields · synced May 30, 2026