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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

iCare without SLIDE. Camera… — Class I MDR by Delmont imaging

MD Atlas
Delmont imaging

EUDAMED last updated this device on May 10, 2023

iCare without SLIDE. Camera control unit only.

37012178ICARG9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Delmont imaging
UDI-DI code: 03701217803008
Reference / catalog number: D100 100 001

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Manufacturer information

Organization name: Delmont imaging
SRN: FR-MF-000000157
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: iCare without SLIDE. Camera control unit only.
UDI-DI code: 03701217803008
Basic UDI-DI: 37012178ICARG9
Reference / catalog number: D100 100 001
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: iCare without SLIDE. Camera control unit only
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12020403MODULES FOR ENDOSCOPIC IMAGING AND MINIMALLY INVASIVE SURGERY

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

Related devices

HD hysteroscope 2,9mm 30° 300mm autoclavable37012178ENDOH7On the market iCare camera head without coupler37012178ICARG9On the market iCare SLIDE. Camera control unit only37012178ICARG9On the market ICE37012178CLVIHROn the market Mangeshikar handle with Pozzi forceps rotation module37012178UTMAMLOn the market

Certificates

Certificate health across this manufacturer's portfolio.

MDR-0021Supplemented
Quality management systemNotified body: 1304Expiry: Nov 7, 2029
MDR-0032Issued
Quality management systemNotified body: 1304Expiry: Oct 16, 2030