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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

Polyster Crowns - Anteriors, 108pcs — Class I MDR

MD Atlas
AnGer G&A Przedsiębiorstwo Produkcyjne

EUDAMED last updated this device on Feb 10, 2022

Polyster Crowns - Anteriors, 108pcs

590761904001EK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AnGer G&A Przedsiębiorstwo Produkcyjne
UDI-DI code: 05907619041262
Reference / catalog number: 8-108

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View device family (Basic UDI)

Manufacturer information

Organization name: AnGer G&A Przedsiębiorstwo Produkcyjne
SRN: PL-MF-000001898
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW020
EUDAMED did not publish a description for this code.
CW318
EUDAMED did not publish a description for this code.
CW218
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: Polyster Crowns - Anteriors, 108pcs
UDI-DI code: 05907619041262
Basic UDI-DI: 590761904001EK
Reference / catalog number: 8-108
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: 108
Additional product description: Set of incisors - 108 pcs in a handy compartment box.
Additional information URL: https://anger.com.pl/index.php?lang=en&controller=product&product=60
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05907619041262

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q01010401PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR 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

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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.