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

Impression tray; DHX 1 — Class I MDR by MEDIN, a.s.

MD Atlas
MEDIN, a.s.

EUDAMED last updated this device on Apr 21, 2026

Impression tray; DHX 1

85917125240308X6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDIN, a.s.
UDI-DI code: 08591712128936
Reference / catalog number: 397154520360

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

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; DHX 1
UDI-DI code: 08591712128936
Basic UDI-DI: 85917125240308X6
Reference / catalog number: 397154520360
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

Related devices

Bandage scissors; 23,5 cm85917125030110VAOn the market Bender; fissure-type, 90°85917125170721Y6On the market Bender; fissure-type, straight85917125170721Y6On the market Bender; pin-type, 40°85917125170721Y6On the market Bender; pin-type, straight85917125170721Y6

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

On the market

2023-MDR/QS-028

Issued

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