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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

Dropper 0,8 — Class I MDR by APON spółka z…

MD Atlas
APON spółka z ograniczoną odpowiedzialnością

EUDAMED last updated this device on Jun 3, 2023

Dropper 0,8

590556787A07046P

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: APON spółka z ograniczoną odpowiedzialnością
UDI-DI code: 05905567870095
Reference / catalog number: 110

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Manufacturer information

Organization name: APON spółka z ograniczoną odpowiedzialnością
SRN: PL-MF-000035395
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: Dropper 0,8
UDI-DI code: 05905567870095
Basic UDI-DI: 590556787A07046P
Reference / catalog number: 110
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: 400
Additional product description: A dropper/drip stick is a medical device intended for the administration/drip into the eyes of a medicinal product in liquid form.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 0.77–0.83 MU50
23.1–24.1 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

A0704SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS

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.

TNP/MDR/0017/0945/2024Supplemented
Quality management systemNotified body: 2274Expiry: Feb 18, 2029