Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

BraceID-Heel Wedge for Walker -… — Class I MDR by Orthobroker

MD Atlas
Orthobroker

EUDAMED last updated this device on Oct 7, 2022

BraceID-Heel Wedge for Walker - Right (Set of 5)

5404020402anklefootAV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orthobroker
UDI-DI code: 05404020401512
Reference / catalog number: 12-0011-R

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Orthobroker
SRN: BE-MF-000000331
Manufacturer status: Active

Related devices

BraceID -Embrace Wrist - Large Left5404020402wristhandZ6On the market BraceID - Abdominal bandage - Medium5404020402trunkheadce5BOn the market BraceID - Abdominal bandage - XXLarge5404020402trunkheadce5BOn the market BraceID - Cervical Collar Med Density - XLarge (12 cm)5404020402trunkheadce5BOn the market BraceID - Contoured Back Support Black - Small5404020402trunkheadce5BOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW030
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Belgium; available across 3 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
France		Still on market
Poland		Still on market

Device identification

Trade name: BraceID-Heel Wedge for Walker - Right (Set of 5)
UDI-DI code: 05404020401512
Basic UDI-DI: 5404020402anklefootAV
Reference / catalog number: 12-0011-R
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

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.

EMDN nomenclature code(s)

Y06120601PASSIVE ANKLE-FOOT ORTHOSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification