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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

1003372/ZR0057 — Class IIa MDR by etol Gesundheitspflege-…

MD Atlas
etol Gesundheitspflege- und Pharmaprodukte GmbH

EUDAMED last updated this device on Mar 19, 2025

1003372/ZR0057

4020928ACOPTX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: etol Gesundheitspflege- und Pharmaprodukte GmbH
UDI-DI code: 04020928000162
Reference / catalog number: 1003372/ZR0057

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Manufacturer information

Organization name: etol Gesundheitspflege- und Pharmaprodukte GmbH
SRN: DE-MF-000005754
Manufacturer status: Active

Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04020928000162
Basic UDI-DI: 4020928ACOPTX
Reference / catalog number: 1003372/ZR0057
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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010299PROSTHETIC DENTISTRY DEVICES - OTHER

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

1003404/ZR00704020928HAC01GQOn the market 1003297/ZR00484020928HAC01GQOn the market 1003475/ZR00754020928HAC01GQOn the market 1003053/ZR00494020928HAC01GQOn the market 1003467/ZR00734020928HAC01GQOn 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.