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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

ZRP 001 — Class IIb MDD by Eonex d.o.o.

MD Atlas
Eonex d.o.o.

EUDAMED last updated this device on Sep 3, 2024

ZRP 001

B-03856027400012

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Eonex d.o.o.
UDI-DI code: 03856027400012
Reference / catalog number: ZRP 001

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Manufacturer information

Organization name: Eonex d.o.o.
SRN: HR-MF-000025730
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Croatia; available across 1 country total.

Country	On market since	Until
CroatiaPrimary placement	Oct 13, 2015	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03856027400012
Basic UDI-DI: B-03856027400012
Reference / catalog number: ZRP 001
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Non-active osteo- and orthopaedic implant
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P09120503OSTEOSYNTHESIS SCREW-PLATE SYSTEMS

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

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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.