Identity
- Trade Name
- DYNASCOPE 1000 Series DS-1700 System EUDAMED
- Device Name
- Measuring and Monitoring Device for Vital Signs EUDAMED
- Model / Reference
- DS-1700LE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612914997 EUDAMED
- Basic UDI-DI
- 4538612021009S EUDAMED
- EMDN Code
- Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
DYNASCOPE 1000 Series DS-1700 System by Fukuda Denshi Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4538612021009S | Class IIb | Active |
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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 (1)
- EUDAMED 48194b19-a9cb-481c-83b5-4a4177035547 61 fields · synced Jun 19, 2026