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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

HANDLE GEARSHIFT FOR OPEN SURGERY — Class I MDR by Brainlab SE

MD Atlas
Brainlab SE

EUDAMED last updated this device on Apr 10, 2024

HANDLE GEARSHIFT FOR OPEN SURGERY

4056481IGSInstHandle8C

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Brainlab SE
UDI-DI code: 04056481001292
Reference / catalog number: 55830-10B

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Manufacturer information

Organization name: Brainlab SE
SRN: DE-MF-000006183
Manufacturer status: Active

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Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: HANDLE GEARSHIFT FOR OPEN SURGERY
UDI-DI code: 04056481001292
Basic UDI-DI: 4056481IGSInstHandle8C
Reference / catalog number: 55830-10B
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: 134 MU50
210 MU24
37 MU50

EMDN nomenclature code(s)

Z12011480SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES

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.

G70 037489 0071Issued
Technical documentationNotified body: 0123Expiry: Mar 15, 2028
G70 037489 0072Issued
Technical documentationNotified body: 0123Expiry: Mar 13, 2028