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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

100008 — Class I MDR by OneMed Group Oy

MD Atlas
OneMed Group Oy

EUDAMED last updated this device on Apr 28, 2025

100008

6438129B0001GU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OneMed Group Oy
UDI-DI code: 06438129000184
Reference / catalog number: 100008

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Manufacturer information

Organization name: OneMed Group Oy
SRN: FI-MF-000000642
Manufacturer status: Active

Related devices

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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.

CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	Mar 31, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06438129000184
Basic UDI-DI: 6438129B0001GU
Reference / catalog number: 100008
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)

T01020204NITRILE EXAMINATION / TREATMENT GLOVES

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
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Software identification