Organization name

Thorwear, Inc (dba Elevate Movement)

SRN

US-MF-000038778

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• Single patient multiple use
• Consult instructions for use
• Contraindications: severe spasticity, leg ulcers, severe edema, severe foot deformities

  OTHER

Primary placement in Germany; available across 14 countries total.

Trade name

SSTEP XLARGE

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.

00850033914160

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.

0850033914SSTEPZP

Reference / catalog number

EAP-0513

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

—

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Y06120601PASSIVE ANKLE-FOOT ORTHOSES

• Class I medical devices in EUDAMED

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