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

HP2253.0402 — Class I MDR by MEDEALIS GmbH

MD Atlas
MEDEALIS GmbH

EUDAMED last updated this device on Jul 18, 2025

HP2253.0402

++EMESK0012W

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDEALIS GmbH
UDI-DI code: +EMESHP225304020
Reference / catalog number: HP2253.0402

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: MEDEALIS GmbH
SRN: DE-MF-000019555
Manufacturer status: Active

Critical warnings

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

CW261
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW147
EUDAMED did not publish a description for this code.
CW026
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW001
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.

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

Device identification

Trade name: not provided
UDI-DI code: +EMESHP225304020
Basic UDI-DI: ++EMESK0012W
Reference / catalog number: HP2253.0402
Issuing entity: HIBCC

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: No additional information URL provided by the manufacturer.
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

HP2253.0400++EMESK0022YOn the market HP2253.0403++EMESB003YYOn the market HP2253.2002++EMESB001YUOn the market HP2253.2000++EMESB001YUOn the market HP2253.2001++EMESB001YUOn 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.