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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

J 77983 — Class I MDR by PROTETIKA, a.s.

MD Atlas
PROTETIKA, a.s.

EUDAMED last updated this device on May 14, 2026

J 77983

858500J77983CL31PL8E

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PROTETIKA, a.s.
UDI-DI code: 08585003409309
Reference / catalog number: J 77983

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View device family (Basic UDI)

Manufacturer information

Organization name: PROTETIKA, a.s.
SRN: SK-MF-000004489
Manufacturer status: Active

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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.

Critical warnings

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

CW275
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Slovakia; available across 3 countries total.

Country	On market since	Until
SlovakiaPrimary placement		Still on market
Czechia		Still on market
Latvia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08585003409309
Basic UDI-DI: 858500J77983CL31PL8E
Reference / catalog number: J 77983
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: Ortéza členka so silikónovými pelotami, Sohatex, ČL-31, pravá, veľkosť L
Additional information URL: https://www.protetika.sk/
Clinical sizes: Ankle circumference (cm) 27-30

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08585003409309

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Y06120601PASSIVE ANKLE-FOOT ORTHOSES

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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