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Organization name
UDI-DI code
Reference / catalog number

Impression tray; FX2 — Class I MDR by MEDIN, a.s.

MD Atlas
MEDIN, a.s.

EUDAMED last updated this device on Apr 21, 2026

Impression tray; FX2

85917125240308X6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDIN, a.s.
UDI-DI code: 08591712128882
Reference / catalog number: 397154520270

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Manufacturer information

Organization name: MEDIN, a.s.
SRN: CZ-MF-000012371
Manufacturer status: Active

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Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
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 Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement		Still on market
Slovakia		Still on market

Device identification

Trade name: Impression tray; FX2
UDI-DI code: 08591712128882
Basic UDI-DI: 85917125240308X6
Reference / catalog number: 397154520270
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: —
Additional information URL: https://eifu.medin.cz/en
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010207DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY

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

Certificates

Certificate health across this manufacturer's portfolio.

2025-MDR/QS-084Issued
Quality management systemNotified body: 2265Expiry: Aug 31, 2028
2024-MDR/TD-058/ASupplemented
Technical documentationNotified body: 2265Expiry: Oct 25, 2029
2024-MDR/QS-058/ASupplemented
Quality management systemNotified body: 2265Expiry: Oct 25, 2029
2023-MDR/TD-028/AIssued
Technical documentationNotified body: 2265Expiry: Aug 31, 2028
2023-MDR/QS-028/AIssued
Quality management systemNotified body: 2265Expiry: Aug 31, 2028

2023-MDR/QS-028

Issued

Quality management systemNotified body: 2265Expiry: Aug 31, 2028