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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

970816 — Class I MDR by MEDEALIS GmbH

MD Atlas
MEDEALIS GmbH

EUDAMED last updated this device on Jul 18, 2025

970816

++EMESK0022Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDEALIS GmbH
UDI-DI code: +EMES9708160
Reference / catalog number: 970816

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Manufacturer information

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

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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: +EMES9708160
Basic UDI-DI: ++EMESK0022Y
Reference / catalog number: 970816
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

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.