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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

001 — Class IIa MDR by Provepharm SAS

MD Atlas
Provepharm SAS

EUDAMED last updated this device on Mar 25, 2024

001

376023716PVDYEEE

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Provepharm SAS
UDI-DI code: 03760237160515
Reference / catalog number: 001

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Manufacturer information

Organization name: Provepharm SAS
SRN: FR-MF-000009343
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement	Sep 1, 2016	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760237160515
Basic UDI-DI: 376023716PVDYEEE
Reference / catalog number: 001
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: ProveDye® is a clear dark blue sterile solution of 0.5% methylene blue (Proveblue®), allowing the surgical visualisation such as intra operative seal tests, leakages visualisation, delineation of fistula tract and visualisation of Sentinel Lymph Nodes (SLN) in oncologic surgery.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 2 MU03

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

002376023716PVDYEEEOn the market 001376023716PVDYEEEOn the market 002376023716PVDYEEEOn the market 001376023716PVDYEEEOn the market 001376023716PVDYEEEOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.