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

100HL0106H — Class I MDR by AGM orthopaedics

MD Atlas
AGM orthopaedics

EUDAMED last updated this device on Sep 27, 2024

100HL0106H

475104097SPAOE6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AGM orthopaedics
UDI-DI code: 04751040972623
Reference / catalog number: 100HL0106H

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: AGM orthopaedics
SRN: LV-MF-000044288
Manufacturer status: Active

Critical warnings

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

CW011
The Acupressure Octopus must NOT be used: in severe spinal injuries during the acute period or infections of the spine; oncological diseases of the spine; in case of skin inflammation, abrasions, wounds in the Acupressure Octopus using area; in case of acute abdominal pain; during pregnancy; chronic obstructive pulmonary disease (COPD). by children and people with mental disorders

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 Latvia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04751040972623
Basic UDI-DI: 475104097SPAOE6
Reference / catalog number: 100HL0106H
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: 170–220 MU10
waist circumference — 105–121 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04751040972623

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

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

Y060306THORACOLUMBAR 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

Related devices

100LS0201N475104097SPAOE6On the market 100LS0105N475104097SPAOE6On the market 100HL0207H475104097SPAOE6On the market 100HL0204H475104097SPAOE6On the market 100HL0201H475104097SPAOE6On 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.