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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

UA1251 — Class I MDR by BK Medical ApS

MD Atlas
BK Medical ApS

EUDAMED last updated this device on May 26, 2026

UA1251

570491601002AF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BK Medical ApS
UDI-DI code: 05704916001438
Reference / catalog number: UA1251

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View device family (Basic UDI)

Manufacturer information

Organization name: BK Medical ApS
SRN: DK-MF-000006447
Manufacturer status: Active

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5P1e Transducer570491600501AXOn the market UA0671570491601201APOn the market UA0673570491601202AROn the market UA0672570491601202AROn the market UA1250570491601002AFOn the market

Certificates

Certificate health across this manufacturer's portfolio.

10000449961-PA-NoMA-DNKIssued
Quality management systemNotified body: 2460Expiry: Jul 17, 2027

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05704916001438
Basic UDI-DI: 570491601002AF
Reference / catalog number: UA1251
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05704916001438

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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.

Z11049099VARIOUS ULTRASOUND INSTRUMENTS - OTHER

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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