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DYNASCOPE 1000 Series DS-1800 System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref DS-1800LRRef DS-1812
Identity
- Trade Name
- DYNASCOPE 1000 Series DS-1800 System EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- Measuring and Monitoring Device for Vital Signs EUDAMED
- Model / Reference
- DS-1800LR EUDAMEDFDA UDIDS-1812 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612915864 EUDAMED04538612915802 EUDAMED04538612915840 FDA UDI04538612915888 FDA UDI
- Basic UDI-DI
- 4538612021009S EUDAMED
- FDA Product Code
- DSI FDA UDI
- EMDN Code
- Z12030201,Z12030602 EUDAMEDZ12030201,Z1203020602 EUDAMED
- GMDN Term
- Centralized patient 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
DYNASCOPE 1000 Series DS-1800 System 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 | 4538612021009S | 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 (5)
- EUDAMED 5c5d5b03-cb79-411a-ae47-7b62aee74ef0 61 fields · synced Sep 18, 2026
- EUDAMED 951162d9-9953-4e7f-a573-1be9f1ce41d9 61 fields · synced May 18, 2026
- FDA UDI fe970cf0-262a-42a5-bf31-e1d594835a0d 32 fields · synced May 30, 2026
- FDA UDI cb601947-6ce5-4afe-bfc0-e01b6fdc8c61 32 fields · synced May 30, 2026
- EUDAMED f6ba8a05-7072-4dad-bea5-de8a3be24f45 61 fields · synced Sep 17, 2026