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Organization name
UDI-DI code
Reference / catalog number

R-15-S — Class IIa MDD by newbox medical GmbH

MD Atlas
newbox medical GmbH

EUDAMED last updated this device on Apr 14, 2026

R-15-S

B-04059216084386

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: newbox medical GmbH
UDI-DI code: 04059216084386
Reference / catalog number: R-15-S

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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: 04059216084386
Basic UDI-DI: B-04059216084386
Reference / catalog number: R-15-S
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Saw Blade – reciprocating, 3,7 mm x 14,5 mm x 0,40 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)

P091302ORTHOPAEDIC IMPLANT BLADES, SINGLE-USE

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