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NIBP Cuff

EUDAMED

Class I (EU MDR)

Ref CUF-250M-LARef CUF-250L-RBRef CUF-250L-LARef CUF-250M-RARef CUF-250S-RA

by Fukuda Denshi Co., Ltd.

Identity

Trade Name
NIBP Cuff EUDAMED
Device Name
Accessories for Sphygmomanometer and Sphygmograph EUDAMED
Model / Reference
CUF-250M-LA EUDAMED
CUF-250L-RB EUDAMED
CUF-250L-LA EUDAMED
CUF-250M-RA EUDAMED
CUF-250S-RA EUDAMED

Identifiers

Primary DI / UDI-DI
04538612915543 EUDAMED
04538612915550 EUDAMED
04538612915581 EUDAMED
04538612915536 EUDAMED
04538612915499 EUDAMED
Basic UDI-DI
4538612011019M EUDAMED
EMDN Code
C9006,Z12050301 EUDAMED
C9006 ANEROID SPHYGMOMANOMETERS EUDAMED

Classification

Device Class
Class I 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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

NIBP Cuff by Fukuda Denshi Co., Ltd. — Class I — 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

Manufacturer
Fukuda Denshi Co., Ltd.
EUDAMED SRN
JP-MF-000008253
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (5)

  • EUDAMED 90da7b58-132f-4c4c-bbc7-45c0837bad69 61 fields · synced Jul 27, 2026
  • EUDAMED a53c8218-aed5-4080-8d0f-49c44d159df6 61 fields · synced May 11, 2026
  • EUDAMED d4b40c0b-36ea-4db0-97ff-bd4a87300115 61 fields · synced May 18, 2026
  • EUDAMED 1b690a1c-966f-449b-a1d1-d418cb9ce1c3 61 fields · synced May 18, 2026
  • EUDAMED ee428fde-bb6e-46eb-af3f-ad8294c96335 61 fields · synced May 19, 2026