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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

CLE1-C1-50-18-230 — Class I MDR by FUJIFILM medwork GmbH

MD Atlas
FUJIFILM medwork GmbH

EUDAMED last updated this device on Apr 26, 2022

CLE1-C1-50-18-230

4044503056194C

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FUJIFILM medwork GmbH
UDI-DI code: 04044503001467
Reference / catalog number: CLE1-C1-50-18-230

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Manufacturer information

Organization name: FUJIFILM medwork GmbH
SRN: DE-MF-000008444
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: not provided
UDI-DI code: 04044503001467
Basic UDI-DI: 4044503056194C
Reference / catalog number: CLE1-C1-50-18-230
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: 5 MU50
230 MU10

EMDN nomenclature code(s)

G03080301GASTROINTESTINAL CYTOLOGY, BRUSHES

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.

1000297126Issued
Quality management systemNotified body: 0297Expiry: Oct 1, 2028