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BKSF-ER, Male, Right, Size: BKSF(24S)

EUDAMED

Class I (EU MDR)

Ref BKSF-ER-M-R-BKSF(24S)

by Regal Prosthesis Limited

Identity

Trade Name
BKSF-ER, Male, Right, Size: BKSF(24S) EUDAMED
Device Name
Silicone Cosmetic Prostheses EUDAMED
Model / Reference
BKSF-ER-M-R-BKSF(24S) EUDAMED

Identifiers

Primary DI / UDI-DI
04895200353614 EUDAMED
Basic UDI-DI
48952003007RX7Z EUDAMED
EMDN Code
Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany 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

Category: Mechanical-resistance external ankle-foot prosthesis

BKSF-ER, Male, Right, Size: BKSF(24S) by Regal Prosthesis Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical-resistance external ankle-foot prosthesis.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Regal Prosthesis Limited
EUDAMED SRN
HK-MF-000028642
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (1)

  • EUDAMED 19fb8a31-7e2a-4b5a-9262-6ee5f58402ee 61 fields · synced Jul 8, 2026