Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

08445773266055 — Class IIa MDR by mark'ennovy…

MD Atlas
mark'ennovy Personalized Care S.L.

EUDAMED last updated this device on Apr 10, 2026

08445773266055

8433108TF03-Gentle5C

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: mark'ennovy Personalized Care S.L.
UDI-DI code: 08445773266055
Reference / catalog number: 08445773266055

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?

Manufacturer information

Organization name: mark'ennovy Personalized Care S.L.
SRN: ES-MF-000001436
Manufacturer status: Active

Related devices

400098433108TF04-GMA-HEMACEOn the market 200318433108TF02-SiliconeLMNOn the market 200328433108TF02-SiliconeLMNOn the market 200298433108TF02-SiliconeLMNOn the market 200308433108TF02-SiliconeLMNOn the market

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

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08445773266055
Basic UDI-DI: 8433108TF03-Gentle5C
Reference / catalog number: 08445773266055
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 13–14 MU50
-30–30 MU104
7.1–9.8 MU50

EMDN nomenclature code(s)

Q0210040102CONTACT LENSES - HYDROGEL, REUSABLE

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