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

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Organization name
UDI-DI code
Reference / catalog number

100HL0105H — Class I MDR by AGM orthopaedics

MD Atlas
AGM orthopaedics

EUDAMED last updated this device on Sep 27, 2024

100HL0105H

475104097SPAOE6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AGM orthopaedics
UDI-DI code: 04751040972616
Reference / catalog number: 100HL0105H

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View device family (Basic UDI)

Manufacturer information

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

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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.

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

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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: 04751040972616
Basic UDI-DI: 475104097SPAOE6
Reference / catalog number: 100HL0105H
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: waist circumference — 93–109 MU10
170–220 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04751040972616

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UDI-PI DataMatrix

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

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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

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