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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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CHIROMEGA 654 NIKA — 1 UDI-DI variant, MDD (CHIROMEGA)

MD Atlas
CHIROMEGA

Data from EUDAMED, last updated May 31, 2026

CHIROMEGA 654 NIKA

B-08588009232025

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIa

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Manufacturer: CHIROMEGA

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Device characteristics

Active device

Legacy certificates

Certificate number: TNP/MDD/0376/5182/2021
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: TUV NORD Polska Sp. z o.o (2274)
Validity: May 11, 2024

Identity & classification

Basic UDI-DI: B-08588009232025
Device name: CHIROMEGA 654 NIKA
Device model: CHIROMEGA 654 Nika
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: Apr 17, 2025

Manufacturer & authorised representative

Manufacturer

Name: CHIROMEGA
SRN: SK-MF-000024150
Country: Slovakia
Email: chiromega@chiromega.sk
Phone: +421577750615

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01JS114W6CEGWXK08D7RTACXFC

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

CHIROMEGA 654 NIKA08588009232025