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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

ME-FD1000L — Class I MDR by MedEnvision bv

MD Atlas
MedEnvision bv

EUDAMED last updated this device on Jan 23, 2023

ME-FD1000L

5430001422MEFDLH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MedEnvision bv
UDI-DI code: 05430001422085
Reference / catalog number: ME-FD1000L

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Manufacturer information

Organization name: MedEnvision bv
SRN: BE-MF-000000329
Manufacturer status: Active

Market distribution

Primary placement in Belgium; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05430001422085
Basic UDI-DI: 5430001422MEFDLH
Reference / catalog number: ME-FD1000L
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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V80CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES

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

ME-FD2000L5430001422MEFDLHOn the market ME-FD3000S5430001422MEFDLHOn the market ME-FD3000L5430001422MEFDLHOn the market ME-FD1000S5430001422MEFDLHOn the market ME-FD50005430001422MEFDLHOn the market

Certificates

Certificate health across this manufacturer's portfolio.

BE25/00000238Supplemented
Quality management systemNotified body: 1639Expiry: Sep 17, 2030