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DYNASCOPE 1000 Series DS-1200 System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref DS-1200NRT
Identity
- Trade Name
- DYNASCOPE 1000 Series DS-1200 System EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Measuring and Monitoring Device for Vital Signs EUDAMED
- Model / Reference
- DS-1200NRT EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612915222 EUDAMED04538612915314 FDA UDI
- Basic UDI-DI
- 4538612020009M EUDAMED
- 510(k) Number
- K150030 FDA UDI
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside 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-1200 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 | 4538612020009M | 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 c3e5c37f-08b2-43ce-8123-e48668e58c0f 61 fields · synced Jul 19, 2026
- FDA UDI 26260abf-4541-4dfc-a57e-abfd72cef2a7 33 fields · synced May 30, 2026