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Organization name
UDI-DI code
Reference / catalog number

SB64-404S — Class IIa MDD by newbox medical GmbH

MD Atlas
newbox medical GmbH

EUDAMED last updated this device on Apr 15, 2026

SB64-404S

B-04059216081835

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: newbox medical GmbH
UDI-DI code: 04059216081835
Reference / catalog number: SB64-404S

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Manufacturer information

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

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SB52-402B-04059216079757On the market SB 60-332B-04059216082139On the market SB 60-332.1B-04059216166396On the market SB30-201B-04059216079160On the market SB30-201.1B-04059216163425On the market

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 30, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04059216081835
Basic UDI-DI: B-04059216081835
Reference / catalog number: SB64-404S
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: SB64-404S
Additional information URL: https://www.newbox-medical.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

K030203ARTHROSCOPY 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