Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

OG-WK001 — Class I MDR by Orthoguard Maciej Tomczuk

MD Atlas
Orthoguard Maciej Tomczuk

EUDAMED last updated this device on Oct 17, 2022

OG-WK001

5903981322ortezyRM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orthoguard Maciej Tomczuk
UDI-DI code: 05903968144654
Reference / catalog number: OG-WK001

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?

View device family (Basic UDI)

Manufacturer information

Organization name: Orthoguard Maciej Tomczuk
SRN: PL-MF-000002247
Manufacturer status: Active

Related devices

OG-EWR0015903981322ortezyRMOn the market OG-EWR0015903981322ortezyRMOn the market OG-EWR0015903981322ortezyRMOn the market OG-EWR001 5903981322ortezyRMOn the market OG-EKN001 5903981322ortezyRMOn 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

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05903968144654
Basic UDI-DI: 5903981322ortezyRM
Reference / catalog number: OG-WK001
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

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

Become a partner of MD Atlas