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DYNASCOPE 1000 Series DS-1700 System

EUDAMED

Class IIb (EU MDR)

Ref DS-1700LRRef DS-1708ERef DS-1708RERef DS-1700LRef DS-1700LRERef DS-1708R

by Fukuda Denshi Co., Ltd.

Identity

Trade Name
DYNASCOPE 1000 Series DS-1700 System EUDAMED
Device Name
Measuring and Monitoring Device for Vital Signs EUDAMED
Model / Reference
DS-1700LR EUDAMED
DS-1708E EUDAMED
DS-1708RE EUDAMED
DS-1700L EUDAMED
DS-1700LRE EUDAMED
DS-1708R EUDAMED

Identifiers

Primary DI / UDI-DI
04538612915017 EUDAMED
04538612915079 EUDAMED
04538612915116 EUDAMED
04538612914973 EUDAMED
04538612915031 EUDAMED
04538612915093 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

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Manufacturer

EUDAMED SRN
JP-MF-000008253
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (6)

  • EUDAMED 562a71ed-c191-41f6-9488-bc5fc42edcce 61 fields · synced Jul 22, 2026
  • EUDAMED c4d89d6d-caa4-482a-910a-36b910573829 61 fields · synced May 17, 2026
  • EUDAMED 00f1a90a-3f4b-4f9a-b804-31f9983ebd01 61 fields · synced May 18, 2026
  • EUDAMED f886c50b-2c0c-42f1-ad43-ad3ebb0137fb 61 fields · synced May 18, 2026
  • EUDAMED 47480eb7-eed6-4de5-9f02-b28676d77474 61 fields · synced May 19, 2026
  • EUDAMED 8d96a8e7-7cf4-4aff-8e8c-9d8be10bb745 61 fields · synced May 19, 2026