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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

ORAL SYRINGE 5ml, CE — Class I MDR by TEHNOPRO d.o.o.

MD Atlas
TEHNOPRO d.o.o.

EUDAMED last updated this device on Mar 8, 2023

ORAL SYRINGE 5ml, CE

385888353OralSyringe5mlNM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TEHNOPRO d.o.o.
UDI-DI code: 03858883539516
Reference / catalog number: 000029

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Manufacturer information

Organization name: TEHNOPRO d.o.o.
SRN: HR-MF-000025711
Manufacturer status: Active

Market distribution

Primary placement in Croatia; available across 1 country total.

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

Device identification

Trade name: ORAL SYRINGE 5ml, CE
UDI-DI code: 03858883539516
Basic UDI-DI: 385888353OralSyringe5mlNM
Reference / catalog number: 000029
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: Oral syringe is completed product of two parts: PE-LD cylinder ( natural color - transparent ) and PS piston ( white color - colored with white masterbatch ) with tampon printed volume scale ( black ink )
Additional information URL: https://tehnopro.hr/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - 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

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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.