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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

MEMOCERVICAL — Class I MDR by BIOSYNEX

MD Atlas
BIOSYNEX

EUDAMED last updated this device on Mar 7, 2024

MEMOCERVICAL

353267F00193O8U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOSYNEX
UDI-DI code: 08055517560501
Reference / catalog number: 3020

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View device family (Basic UDI)

Manufacturer information

Organization name: BIOSYNEX
SRN: FR-MF-000014073
Manufacturer status: Active

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 Italy; available across 1 country total.

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

Device identification

Trade name: MEMOCERVICAL
UDI-DI code: 08055517560501
Basic UDI-DI: 353267F00193O8U
Reference / catalog number: 3020
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: GUANCIALE MEMOCERVICAL 7 BLUE - DOPPIA ONDA
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08055517560501

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

V080399MEDICAL CUSHIONS - 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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Certificates

Certificate health across this manufacturer's portfolio.

030/MDRIssued
Quality management systemNotified body: 0051Expiry: Jun 5, 2027
G10 002187 0009Issued
Quality management systemNotified body: 0123Expiry: Sep 25, 2028