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

OrthoSOLID- CARPI Wrist… — Class I MDR by Orthobroker

MD Atlas
Orthobroker

EUDAMED last updated this device on Nov 2, 2023

OrthoSOLID- CARPI Wrist Orthosis-Long Left

5404020402wristhandZ6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orthobroker
UDI-DI code: 05404020402557
Reference / catalog number: OS-301-CA

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

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

CW011
In the event of abnormal swelling, skin discolouration or the occurrence of discomfort, discontinue use and consult the healthcare provider. • The orthosis should be comfortable and snug, without disrupting blood circulation. • If the orthosis is applied over open or infected wounds, provide appropriate wound care.
CW010
EUDAMED did not publish a description for this code.
CW262
This orthosis must be worn strictly according to the instructions for use.
CW030
EUDAMED did not publish a description for this code.
CW999
Contra-indications •Severe sprains •Immediate treatment following fractures IMPORTANT INFORMATION •This orthosis must be worn strictly according to the instructions for use. •The product is intended for use by a single patient •We cannot be held responsible in the event of improper use. •Warranty is granted within the framework of the legal provisions •Do not place the orthosis near extremely high heat sources. •Measurement and application must be carried out by a certified (para)medic.

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: OrthoSOLID- CARPI Wrist Orthosis-Long Left
UDI-DI code: 05404020402557
Basic UDI-DI: 5404020402wristhandZ6
Reference / catalog number: OS-301-CA
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: Measurement and application must be carried out by a certified (para)medic.

EMDN nomenclature code(s)

Y060609WRIST (FOREARM) 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