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Organization name
UDI-DI code
Reference / catalog number

13138-9528.A — Class IIb MDR by newbox medical GmbH

MD Atlas
newbox medical GmbH

EUDAMED last updated this device on Apr 9, 2026

13138-9528.A

4059216KW0C4

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: newbox medical GmbH
UDI-DI code: 04059216168369
Reference / catalog number: 13138-9528.A

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Manufacturer information

Organization name: newbox medical GmbH
SRN: DE-MF-000020279
Manufacturer status: Active

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Oct 1, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04059216168369
Basic UDI-DI: 4059216KW0C4
Reference / catalog number: 13138-9528.A
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: K-Draht 110 x 2,8 mm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P09120301KIRSCHNER BONE WIRES

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.

MDR-0019Amended
Quality management systemNotified body: 1304Expiry: Oct 15, 2029