T-Handle, Assy, for Strike Plate Frame (Shukla Knee S9KNEE +2 more)

EUDAMED

Class I (EU MDR)

Ref SHN019

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

Identity

Trade Name: T-Handle, Assy, for Strike Plate Frame (Shukla Knee S9KNEE, Shukla Nail S9NAIL, Shukla Anterior Hip S9HIP-ANT Implant Extraction Systems) EUDAMED
Device Name: T-Handle, Assy, for Strike Plate Frame (Shukla Knee S9KNEE, Shukla Nail S9NAIL, Shukla Anterior Hip S9HIP-ANT Implant Extraction Systems) EUDAMED
Model / Reference: SHN019 EUDAMED

Identifiers

Primary DI / UDI-DI: +B756SHN0190 EUDAMED
Basic UDI-DI: ++B756SHN019X2 EUDAMED
Direct Marketing DI: +B756SHN0190 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 Implant Extraction Systems EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: Northern Ireland EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

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

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	++B756SHN019X2	Class I	Active

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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 213a01a5-dc95-49b0-b361-7dcfa3540321 61 fields · synced Jun 19, 2026