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Organization name
UDI-DI code
Reference / catalog number

08445773220859 — Class IIa MDR by mark'ennovy…

MD Atlas
mark'ennovy Personalized Care S.L.

EUDAMED last updated this device on Apr 9, 2026

08445773220859

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: 08445773220859
Reference / catalog number: 08445773220859

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Manufacturer information

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

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.

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 Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08445773220859
Basic UDI-DI: 8433108TF03-Gentle5C
Reference / catalog number: 08445773220859
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: 7.1–9.8 MU50
13–16 MU50
-30–30 MU104
-8–-0.75 MU104
5–180 MU105

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
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Software identification