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Strike Plate, Assy, Frame (Shukla Knee S9KNEE +2 more)

EUDAMED

Class I (EU MDR)

Ref SBD008

by S. S. White Technologies Inc/DBA Shukla Medical

Identity

Trade Name
Strike Plate, Assy, Frame (Shukla Knee S9KNEE, Shukla Nail S9NAIL, Shukla Anterior Hip S9HIP-ANT Extraction Systems) EUDAMED
Device Name
Strike Plate, Assy, Frame (Shukla Knee S9KNEE, Shukla Nail S9NAIL, Shukla Anterior Hip S9HIP-ANT Extraction Systems)) EUDAMED
Model / Reference
SBD008 EUDAMED

Identifiers

Primary DI / UDI-DI
+B756SBD0080 EUDAMED
Basic UDI-DI
++B756SBD008SM EUDAMED
Direct Marketing DI
+B756SBD0080 EUDAMED
EMDN Code
L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Models / Variants
Shukla Knee S9KNEE EUDAMED
Shukla Nail S9NAIL EUDAMED
Shukla Anterior Hip S9HIP-ANT Extraction Systems EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Northern Ireland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

Strike Plate, Assy, Frame (Shukla Knee S9KNEE +2 more) by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed in EUDAMED — 3 models

Manufacturer's product page: Product Guide: SHUKLA Hip (S9HIP)

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
S. S. White Technologies Inc/DBA Shukla Medical
EUDAMED SRN
US-MF-000007058
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (1)

  • EUDAMED 9df2124b-1785-4d96-a57a-ad653a66f358 61 fields · synced Oct 5, 2026