Organization name

Biometrics Ltd

SRN

GB-MF-000002774

Manufacturer status

Active

Primary placement in Malta; available across 32 countries total.

Trade name

BF8 BaseFrame

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05060481690362

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

506048169AccessoriesRBSY

Reference / catalog number

BF8 BaseFrame

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The BF8 BaseFrame is designed to hold multiple FP3 ForcePlates in a variety of positions on the floor to accommodate a wide range of subject sizes with different stance widths.The BaseFrame has cutouts which usually hold 2 or 4 ForcePlates and comes with 8 BP1 blanks to fill any unused cutouts. The integral handle makes the BaseFrame easily portable and the non skid strips on the bottom prevent sliding on floors or carpet.

Additional information URL

https://biometricselink.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12062480BIOFEEDBACK INSTRUMENTS - HARDWARE ACCESSORIES

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.