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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

Embra® Surgical hood James… — Class I MDR by OneMed Group Oy

MD Atlas
OneMed Group Oy

EUDAMED last updated this device on Feb 12, 2026

Embra® Surgical hood James tie-on, blue

6438129B0043HC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OneMed Group Oy
UDI-DI code: 06438129001068
Reference / catalog number: 277403

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Manufacturer information

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

Related devices

1000086438129B0001GUOn the market 1000096438129B0001GUOn the market 1000076438129B0001GUOn the market 1000106438129B0001GUOn the market 1000066438129B0001GUOn the market

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW007
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	Feb 11, 2026	Still on market

Device identification

Trade name: Embra® Surgical hood James tie-on, blue
UDI-DI code: 06438129001068
Basic UDI-DI: 6438129B0043HC
Reference / catalog number: 277403
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)

T0207CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)

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

Certificates

Certificate health across this manufacturer's portfolio.

10000510541-PA-NoMA-DNKIssued
Quality management systemNotified body: 2460Expiry: Jul 6, 2027
10000510540-PA-NoMA-DNKIssued
Quality management systemNotified body: 2460Expiry: May 18, 2027