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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

E8062-KIT — Class I MDR by Embreis AB

MD Atlas
Embreis AB

EUDAMED last updated this device on May 4, 2026

E8062-KIT

73401896172QQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Embreis AB
UDI-DI code: 07340189642251
Reference / catalog number: E8062-KIT

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View device family (Basic UDI)

Manufacturer information

Organization name: Embreis AB
SRN: SE-MF-000003023
Manufacturer status: Active

Related devices

E8061PS0573401896172QQOn the market E8061PS0373401896172QQOn the market E80610073401896172QQOn the market E80710073401896172QQOn the market E80711773401896172QQOn 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

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

CW010
For full details on safe use, contraindications and precautions, consult the IFU before use.
CW262
Intended for multiple use on a single patient only. Re‑use on another patient is not permitted.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	May 4, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07340189642251
Basic UDI-DI: 73401896172QQ
Reference / catalog number: E8062-KIT
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: Ankle-foot orthosis intended for adults with drop foot or reduced dorsiflexion
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

UDI-DI DataMatrix

Encoded

(01)07340189642251

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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.

Y06120602ENERGY RETURN 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

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