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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

Compatible Analog - Biotech Kontact — Class I MDR

MD Atlas
EXAKTUS - Material de Reabilitação Oral, S.A.

EUDAMED last updated this device on Jun 3, 2022

Compatible Analog - Biotech Kontact

5600707883ANALOGUESFM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EXAKTUS - Material de Reabilitação Oral, S.A.
UDI-DI code: 05600707883330
Reference / catalog number: BTC001

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View device family (Basic UDI)

Manufacturer information

Organization name: EXAKTUS - Material de Reabilitação Oral, S.A.
SRN: PT-MF-000014249
Manufacturer status: Active

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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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Portugal; available across 1 country total.

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

Device identification

Trade name: Compatible Analog - Biotech Kontact
UDI-DI code: 05600707883330
Basic UDI-DI: 5600707883ANALOGUESFM
Reference / catalog number: BTC001
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://u7m5t6a5.stackpathcdn.com/wp-content/uploads/2022/05/DOC.04-E1_Instructions-for-Use_Analogues.pdf
Clinical sizes: KONTACT

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05600707883330

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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.

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

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