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Organization name
UDI-DI code
Reference / catalog number

Dosing measure 14/15 ml — Class I MDD by APON spółka z…

MD Atlas
APON spółka z ograniczoną odpowiedzialnością

EUDAMED last updated this device on Jun 3, 2023

Dosing measure 14/15 ml

B-05905567870040

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: APON spółka z ograniczoną odpowiedzialnością
UDI-DI code: 05905567870040
Reference / catalog number: 212

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Manufacturer information

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

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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

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: Dosing measure 14/15 ml
UDI-DI code: 05905567870040
Basic UDI-DI: B-05905567870040
Reference / catalog number: 212
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The dosing measuring cup is attached to the bottle/package with the liquid medicinal product. It is used to measure and administer the medicine.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 2–15 MU03

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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