Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

MK-510WI — IVDR Class A IVDR by NIHON KOHDEN FIRENZE…

MD Atlas
NIHON KOHDEN FIRENZE S.r.l.

EUDAMED last updated this device on Jul 11, 2025

MK-510WI

805461527IVD0004B6

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: NIHON KOHDEN FIRENZE S.r.l.
UDI-DI code: 08054615270800
Reference / catalog number: MK-510WI

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

Organization name: NIHON KOHDEN FIRENZE S.r.l.
SRN: IT-MF-000007607
Manufacturer status: Active

Related devices

MEK-520I805461527IVD0001AYOn the market MEK-620I805461527IVD0001AYOn the market MK-710WI805461527IVD0001AYOn the market MK-310WI805461527IVD0003B4On the market MEK-680I805461527IVD0003B4On the market

Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW044
EUDAMED did not publish a description for this code.
CW096
EUDAMED did not publish a description for this code.
CW137
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW313
EUDAMED did not publish a description for this code.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08054615270800
Basic UDI-DI: 805461527IVD0004B6
Reference / catalog number: MK-510WI
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://nkf.it/wp-content/uploads/IFU_A.pdf
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08054615270800

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

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

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

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

W0103010105CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Become a partner of MD Atlas

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.