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Organization name
UDI-DI code
Reference / catalog number

Stryker Advanced Imaging 10 mm… — Class I MDR

MD Atlas
Asensus Surgical Italia S.r.l.

EUDAMED last updated this device on Oct 11, 2022

Stryker Advanced Imaging 10 mm Endoscope Adapter

081544002TD006UP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Asensus Surgical Italia S.r.l.
UDI-DI code: 00815440020323
Reference / catalog number: X9007601

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Manufacturer information

Organization name: Asensus Surgical Italia S.r.l.
SRN: IT-MF-000007964
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

ITH 1024597 1Amended
Quality management systemNotified body: 1936Expiry: Jun 30, 2027

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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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: Stryker Advanced Imaging 10 mm Endoscope Adapter
UDI-DI code: 00815440020323
Basic UDI-DI: 081544002TD006UP
Reference / catalog number: X9007601
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: The Senhance Adapters are accessory devices used with the Asensus Surgical’s Senhance Surgical System (Senhance system). The Senhance system is a console based, multi-arm surgical system which enables a surgeon to remotely control surgical instrumentation during laparoscopic and thoracoscopic surgery. The Senhance Adapters are designed to provide the mechanism which allows the Senhance Surgical Instruments and endoscopes to interface with the robotic manipulator arms of the Senhance system. Each surgical instrument or endoscope is paired with a unique, corresponding adapter, which is laser-marked to facilitate matching with the associated device. The adapters include non-energized and energized designs for use with the Senhance passive, monopolar, and bipolar surgical instruments and compatible endoscope camera systems.
Additional information URL: https://ifu.asensus.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z1202018099REMOTE CONTROL ROBOT-ASSISTED ENDOSCOPIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES - 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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