Pinless Femur Reference Array

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 52400-01A

by Brainlab SE

Identity

Trade Name: Pinless Femur Reference Array EUDAMEDFDA UDI
Generic Name: Robotic surgical navigation system FDA UDI
Device Name: Pinless Femur Reference Array EUDAMED
Model / Reference: 52400-01A EUDAMEDFDA UDI

Identifiers

Catalog Number: 52400-01A FDA UDI
Primary DI / UDI-DI: 04056481002411 EUDAMEDFDA UDI
Basic UDI-DI: 4056481PinlessFemurRefKH EUDAMED
Direct Marketing DI: 04056481002411 EUDAMED
FDA Product Code: OLO FDA UDI
EMDN Code: Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Robotic surgical navigation system FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Multi-purpose stereotactic surgery system

Pinless Femur Reference Array by Brainlab SE — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose stereotactic surgery system.

PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
TRIALTIS Spine System — MEDOS INTERNATIONAL SARL · Class IIa
PEEK INSTRUMENT ADAPTOR Ø4.6MM — MEDTECH LLC · Class II
Mo¨ller® — MEDTRONIC NAVIGATION, INC. · Class II
StealthStation® S7® — MEDTRONIC NAVIGATION, INC. · Class II
NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	4056481PinlessFemurRefKH	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Brainlab SE
EUDAMED SRN: DE-MF-000006183

Sources (2)

EUDAMED ad6c0291-cdd3-4240-aee9-63fe4004c5fb 61 fields · synced Jul 9, 2026
FDA UDI ec7a7b6e-de33-474c-9130-b8dec0a109dc 35 fields · synced May 30, 2026